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FDA 510(k)

CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM

K-Number: K882092 · 1988-07-13

ApplicantGaymar Industries, Inc.
Decision Date1988-07-13
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1988-07-13 under 510(k) number K882092. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM?

CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1988-07-13. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K882092.

When did CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM receive FDA 510(k) clearance?

CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM received FDA 510(k) clearance on 1988-07-13, under 510(k) number K882092.

Who is the listed applicant for CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM?

The FDA 510(k) record lists Gaymar Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM?

The FDA product code for CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM is FNM.

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Other records listing Gaymar Industries, Inc. as applicant

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Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, Inc.

Official Source

View on FDA Database →

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

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