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FDA 510(k)

SURGICAL APPAREL

K-Number: K935199 · 1994-09-30

ApplicantAssociated Hospital Services, Inc.
Decision Date1994-09-30
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL APPAREL is the device name listed in this FDA 510(k) record. The listed applicant is Associated Hospital Services, Inc.. It received FDA 510(k) clearance on 1994-09-30 under 510(k) number K935199. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL APPAREL?

SURGICAL APPAREL is a medical device that received FDA 510(k) clearance on 1994-09-30. The listed applicant is Associated Hospital Services, Inc.. The 510(k) number is K935199.

When did SURGICAL APPAREL receive FDA 510(k) clearance?

SURGICAL APPAREL received FDA 510(k) clearance on 1994-09-30, under 510(k) number K935199.

Who is the listed applicant for SURGICAL APPAREL?

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

What is the FDA product code for SURGICAL APPAREL?

The FDA product code for SURGICAL APPAREL is KKY.

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.

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Related PubMed Literature

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.

PMID: 30016835Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order.Federal register ()

Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USAK111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

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

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