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FDA 510(k)

SOF. CARE CUSHION & SOF-CARE CUSHION COVER

K-Number: K851027 · 1985-06-18

ApplicantGaymar Industries, Inc.
Decision Date1985-06-18
Product CodeKIC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOF. CARE CUSHION & SOF-CARE CUSHION COVER 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 1985-06-18 under 510(k) number K851027. The device is classified under product code KIC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF. CARE CUSHION & SOF-CARE CUSHION COVER?

SOF. CARE CUSHION & SOF-CARE CUSHION COVER is a medical device that received FDA 510(k) clearance on 1985-06-18. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K851027.

When did SOF. CARE CUSHION & SOF-CARE CUSHION COVER receive FDA 510(k) clearance?

SOF. CARE CUSHION & SOF-CARE CUSHION COVER received FDA 510(k) clearance on 1985-06-18, under 510(k) number K851027.

Who is the listed applicant for SOF. CARE CUSHION & SOF-CARE CUSHION COVER?

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 SOF. CARE CUSHION & SOF-CARE CUSHION COVER?

The FDA product code for SOF. CARE CUSHION & SOF-CARE CUSHION COVER is KIC.

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Other records listing Gaymar Industries, 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.

K100585MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPK962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMK963067SOF. PRESS EPC 51 SYSTEMK961854SPR PLUS II OVERLAY SYSTEM (CL250/CL212K942881TC 3000

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Related Devices (Code: KIC)

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.

K960189GEL-T CUSHIONSpan-America Medical Systems, Inc.K953352PROTEAM CUSHIONIskra.MedK954117CUSTOMCARE SEATING SYSTEMSpan-America Medical Systems, Inc.K950085MULTICURE(R) S GEL PADMultigestion (Deutschland) GmbHK945667MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHIONMicos Medical SystemsK941858GEL CUSHIONHollister, 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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