FDA 510(k)

COTTON UNDER CAST PADDING

K-Number: K800195 · 1980-02-11

Decision Date1980-02-11

Product CodeITG

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

COTTON UNDER CAST PADDING is the device name listed in this FDA 510(k) record. The listed applicant is Winn Hirsch & Assoc.. It received FDA 510(k) clearance on 1980-02-11 under 510(k) number K800195. The device is classified under product code ITG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTTON UNDER CAST PADDING?

COTTON UNDER CAST PADDING is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Winn Hirsch & Assoc.. The 510(k) number is K800195.

When did COTTON UNDER CAST PADDING receive FDA 510(k) clearance?

COTTON UNDER CAST PADDING received FDA 510(k) clearance on 1980-02-11, under 510(k) number K800195.

Who is the listed applicant for COTTON UNDER CAST PADDING?

The FDA 510(k) record lists Winn Hirsch & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COTTON UNDER CAST PADDING?

The FDA product code for COTTON UNDER CAST PADDING is ITG.

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Other records listing Winn Hirsch & Assoc. as applicant

K880309TYPE 316L STAINLESS STEEL WIRE K864375TYPE 316L COTTER WIRE K832214GAUZE CONVERSION CLASS I-NON-STERILE K832213GAUZE CONVERSION CLASS II STERILE K830511ZANLEX, ZAN-TEX & ZANDEX K812390NEUROSPONGE PADDIE

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Related Devices (Code: ITG)

K873111CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.K862115DEKNA BAND KITDeknatel, Inc.K842573T.P.G. CAST TAPEThe Poly Group, Inc.K840416HEXCELITEHexcel Medical K833732NON WETTING UNDERCAST PADDINGAmerican Medical Disposable, Inc.K832992SOFFBAN ORTHOPEDIC PADDINGSmith & Nephew, 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.