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510(k) K951474

TLC SURGICAL DRAPES by Tlc Tech Lab Clothes, Inc. — Product Code KKY

K951474 is an FDA 510(k) premarket notification submitted by Tlc Tech Lab Clothes, Inc. for the device "TLC SURGICAL DRAPES". The FDA issued a decision of Substantially Equivalent on August 18, 1995. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Tlc Tech Lab Clothes, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1995
Date Received
March 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

Other clearances by Tlc Tech Lab Clothes, Inc.

  • K951623 — TLC SURGICAL GOWNS (August 18, 1995)

Other clearances for product code KKY

  • K211514 — Longeviti PorousFit implant (July 15, 2021)
  • K161052 — OsteoFab Patient Specific Facial Device (July 20, 2016)
  • K160988 — Biopor, AOC Porous Polyethylene, Cerepor (July 14, 2016)
  • K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (April 16, 2015)
  • K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (July 28, 2014)
  • K140437 — SU-POR SURGICAL IMPLANT (June 13, 2014)
  • K133046 — OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (May 14, 2014)
  • K123908 — OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES (July 31, 2013)
  • K111323 — SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS (November 16, 2011)
  • K103010 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (October 26, 2010)

FDA data resources