FDA 510(k)

AMERICAN BURN SHEET

K-Number: K922143 · 1992-08-10

Decision Date1992-08-10

Product CodeKME

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AMERICAN BURN SHEET is the device name listed in this FDA 510(k) record. The listed applicant is American Silk Sutures, Inc.. It received FDA 510(k) clearance on 1992-08-10 under 510(k) number K922143. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN BURN SHEET?

AMERICAN BURN SHEET is a medical device that received FDA 510(k) clearance on 1992-08-10. The listed applicant is American Silk Sutures, Inc.. The 510(k) number is K922143.

When did AMERICAN BURN SHEET receive FDA 510(k) clearance?

AMERICAN BURN SHEET received FDA 510(k) clearance on 1992-08-10, under 510(k) number K922143.

Who is the listed applicant for AMERICAN BURN SHEET?

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

What is the FDA product code for AMERICAN BURN SHEET?

The FDA product code for AMERICAN BURN SHEET is KME.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Silk Sutures, Inc. as applicant

K904514STRUNG TELFA NON-ADHERENT SPONGE K902921RAYON NEUROLOGICAL SPONGE K872810STRUNG DENTAL ROLLS K872951AMERICAN BRAIN RETRACTOR COVER K872905AMERICAN NASAL SPONGE K872906SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE

View all 14 devices →

Related Devices (Code: KME)

K042145READY-HEAT BLANKETTechtrade, LLC K944953OREX MEDICAL BEDDINGThantex Specialties, Inc.K933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog Down K915303FOIL BABY BUNTINGGam Industries, Inc.K912257CHEM-SLEEVE BHaz-Med, 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.