Home / 510(k) Clearances / K891214

510(k) K891214

DENTAL SURGICAL WRAP #3007 A,B,C by Pro-Safe Professional Linens, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1989
Date Received
March 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Pro-Safe Professional Linens, Inc.

  • K891210 — POCKETED WRAPS #3009 A,B,C (October 13, 1989)
  • K891216 — DENTAL EQUIPMENT PROTECTION DEVICES (June 2, 1989)
  • K891215 — FAST WRAP #M 101 (April 14, 1989)
  • K891211 — SURGICAL GOWN #2001 (April 14, 1989)
  • K891212 — APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE (April 14, 1989)
  • K891213 — SURGICAL INSTRUMENT POUCH #M102 (April 14, 1989)

Other clearances for product code KCT

  • K253791 — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula Syste (February 26, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K251756 — Sterilization Trays (November 14, 2025)
  • K243425 — Guided DAS Surgical Kit (July 22, 2025)
  • K251300 — Plastic Surgical Kits (July 22, 2025)
  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K250029 — ONE TRAY® Sealed Sterilization Container System (May 1, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)