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510(k) K951811

OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK by Osteotech, Inc. — Product Code LRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1995
Date Received
April 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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Other clearances for product code LRP

  • K963723 — LACERATION TRAY (November 27, 1996)
  • K940239 — EYE TRAY (June 28, 1994)
  • K935621 — CUSTOM ENT PACKS (March 30, 1994)
  • K940646 — ORTHOPEDIC TRAY PRODUCT LINE (March 11, 1994)
  • K940444 — GENERAL SURGERY TRAY (March 7, 1994)
  • K922126 — HOSPITAL KIT ENT 1125 (January 21, 1993)
  • K912105 — EYE TRAY (August 29, 1991)
  • K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (July 29, 1991)
  • K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY (July 29, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)