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FDA 510(k)

SOFT SILICONE ELASTOMER SPONGE EXPLANT

K-Number: K780987 · 1978-09-28

ApplicantMedical Instrument Research Assoc., Inc.
Decision Date1978-09-28
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOFT SILICONE ELASTOMER SPONGE EXPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Research Assoc., Inc.. It received FDA 510(k) clearance on 1978-09-28 under 510(k) number K780987. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT SILICONE ELASTOMER SPONGE EXPLANT?

SOFT SILICONE ELASTOMER SPONGE EXPLANT is a medical device that received FDA 510(k) clearance on 1978-09-28. The listed applicant is Medical Instrument Research Assoc., Inc.. The 510(k) number is K780987.

When did SOFT SILICONE ELASTOMER SPONGE EXPLANT receive FDA 510(k) clearance?

SOFT SILICONE ELASTOMER SPONGE EXPLANT received FDA 510(k) clearance on 1978-09-28, under 510(k) number K780987.

Who is the listed applicant for SOFT SILICONE ELASTOMER SPONGE EXPLANT?

The FDA 510(k) record lists Medical Instrument Research Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT SILICONE ELASTOMER SPONGE EXPLANT?

The FDA product code for SOFT SILICONE ELASTOMER SPONGE EXPLANT is HOZ.

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Other records listing Medical Instrument Research Assoc., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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