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510(k) K970152

BIOPSY TRAY by Medcare Medical Group, Inc. — Product Code FRG

Clearance Details

Decision
SN ()
Decision Date
March 5, 1997
Date Received
January 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Medcare Medical Group, Inc.

  • K973497 — HUBERLOC (January 13, 1998)
  • K962849 — CATHETER INSERTION TRAY (October 7, 1996)
  • K961075 — MEDCARE REGIONAL ANETHESIA KIT (September 6, 1996)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K962527 — GENERAL PURPOSE DENTAL TRAY (August 1, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K961167 — MEDCARE TRACHEOSTOMY CARE TRAY (July 2, 1996)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)