FDA 510(k), K974837, IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS

FDA 510(k), K974837, IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS

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510(K) Number: K974837
Device Name: IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
Manufacturer: JOHN M SZABOCSIK
Device Classification Name: Lenses, Soft Contact, Daily Wear
Regulation Number: LPL
Classification Product Code: KXA
Date Received: 12/24/1997
Decision Date: 07/06/1998
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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