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FDA 510(k)

TLC SURGICAL DRAPES

K-Number: K951474 · 1995-08-18

ApplicantTlc Tech Lab Clothes, Inc.
Decision Date1995-08-18
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TLC SURGICAL DRAPES is the device name listed in this FDA 510(k) record. The listed applicant is Tlc Tech Lab Clothes, Inc.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K951474. 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 TLC SURGICAL DRAPES?

TLC SURGICAL DRAPES is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Tlc Tech Lab Clothes, Inc.. The 510(k) number is K951474.

When did TLC SURGICAL DRAPES receive FDA 510(k) clearance?

TLC SURGICAL DRAPES received FDA 510(k) clearance on 1995-08-18, under 510(k) number K951474.

Who is the listed applicant for TLC SURGICAL DRAPES?

The FDA 510(k) record lists Tlc Tech Lab Clothes, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TLC SURGICAL DRAPES?

The FDA product code for TLC SURGICAL DRAPES 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.

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 Tlc Tech Lab Clothes, 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.

K951623TLC SURGICAL GOWNS

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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