SOFT SILICONE ELASTOMER SPONGE EXPLANT— 510(k) K780987

Name: FDA 510(k) clearance K780987
Creator: U.S. Food and Drug Administration
Published: 1978-09-28

Substantially Equivalent

Medical Instrument Research Assoc., Inc.

FDA 510(k) clearance K780987 for SOFT SILICONE ELASTOMER SPONGE EXPLANT, Substantially Equivalent on 1978-09-28. Applicant: Medical Instrument Research Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Medical Instrument Research Assoc., Inc.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1978-06-14
Decision date: 1978-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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