SOFT SILICONE ELASTOMER SPONGE EXPLANT— 510(k) K780987

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..

Clearance details

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

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