FDA 510(k), K944699, ATT-300

FDA 510(k), K944699, ATT-300

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510(K) Number: K944699
Device Name: ATT-300
Manufacturer: HEALTH CARE MFG., INC.
Device Classification Name: Equipment, Traction, Powered
Regulation Number: 890.5900
Classification Product Code: ITH
Date Received: 09/23/1994
Decision Date: 05/26/1995
Regulation Medical Specialty: Physical Medicine

Total Pages: 140
Fully Redacted Pages: 69
Content Pages: 71

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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