FDA 510(k) K911425, ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM, by Intersurgical, Inc.

FDA 510(k) K911425, ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM, by Intersurgical, Inc.

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Device Classification Name: Connector, Airway (Extension)
510(k) Number: K911425
Device Name: ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
Applicant: Intersurgical, Inc.
Regulation Number: 868.5810
Classification Product Code: BZA
Date Received: 02/05/1991
Decision Date: 06/24/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: Anesthesiology

Total number of pages: 110
Fully redacted pages: 12
Content pages: 98

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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