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FDA 510(k)

SKIN PRESSURE PROTECTORS

K-Number: K761268 · 1977-02-16

ApplicantMark One Healthcare Products
Decision Date1977-02-16
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIN PRESSURE PROTECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Mark One Healthcare Products. It received FDA 510(k) clearance on 1977-02-16 under 510(k) number K761268. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN PRESSURE PROTECTORS?

SKIN PRESSURE PROTECTORS is a medical device that received FDA 510(k) clearance on 1977-02-16. The listed applicant is Mark One Healthcare Products. The 510(k) number is K761268.

When did SKIN PRESSURE PROTECTORS receive FDA 510(k) clearance?

SKIN PRESSURE PROTECTORS received FDA 510(k) clearance on 1977-02-16, under 510(k) number K761268.

Who is the listed applicant for SKIN PRESSURE PROTECTORS?

The FDA 510(k) record lists Mark One Healthcare Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIN PRESSURE PROTECTORS?

The FDA product code for SKIN PRESSURE PROTECTORS is FMP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mark One Healthcare Products 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.

K891986MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCEK833867PAREMA K BAND NON-STERILEK833084MASTERHINGEK770396DRAPES, MODESTY

Related Devices (Code: FMP)

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.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.K811184SPENCO DERMAL PADSSpenco Medical Corp.K802829SCANLAN VASCU-STATTScanlan Intl., Inc.

Official Source

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