TLC SURGICAL DRAPES— 510(k) K951474

Substantially Equivalent

Tlc Tech Lab Clothes, Inc.

FDA 510(k) clearance K951474 for TLC SURGICAL DRAPES, Substantially Equivalent on 1995-08-18. Applicant: Tlc Tech Lab Clothes, Inc.. Device class: 2.

Clearance details

Applicant: Tlc Tech Lab Clothes, Inc.
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 1995-03-30
Decision date: 1995-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Muskegon, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKY

K211514 — Longeviti PorousFit implant2021-07-15
K161052 — OsteoFab Patient Specific Facial Device2016-07-20
K160988 — Biopor, AOC Porous Polyethylene, Cerepor2016-07-14
K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR2015-04-16
K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE2014-07-28

More clearances from Tlc Tech Lab Clothes, Inc.

K951623 — TLC SURGICAL GOWNS1995-08-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.