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510(k) K951231

ORTHOPEDIC PACKS by Sterile Concepts, Inc. — Product Code GAN

K951231 is an FDA 510(k) premarket notification submitted by Sterile Concepts, Inc. for the device "ORTHOPEDIC PACKS". The FDA issued a decision of Substantially Equivalent on December 1, 1995. The device falls under product code GAN (Suture, Absorbable, Synthetic), a Class II device regulated under 21 CFR 878.4830. Sterile Concepts, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1995
Date Received
March 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic
Device Class
Class II
Regulation Number
878.4830
Review Panel
SU
Submission Type

Other clearances by Sterile Concepts, Inc.

  • K951081 — OB/GYN PACKS (November 13, 1995)
  • K952539 — RADIOLOGY PACKS (July 14, 1995)
  • K951478 — GENERAL AND PLASTIC SURGERY PACKS (June 13, 1995)
  • K944139 — DENTAL HYGIENE TRAY (December 15, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K943090 — SUTURE REMOVAL TRAYS (August 22, 1994)
  • K940864 — DENTIST WITH ASSISTANT PACK (August 2, 1994)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)
  • K920763 — LACERATTION TRAY (September 28, 1992)

Other clearances for product code GAN

  • K003015 — SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD (December 15, 2000)
  • K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (December 18, 1996)
  • K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) (March 28, 1996)
  • K920978 — ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED (February 15, 1994)
  • K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (July 5, 1990)
  • K895579 — POLYSORB SYNTHETIC ABSORBABLE SUTURE (July 5, 1990)

FDA data resources