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510(k) K933148

SURGICAL DRAPE KIT by Nobelpharma USA, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1995
Date Received
June 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Nobelpharma USA, Inc.

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  • K962403 — NOBLEPHARMA WIDE ACCESSORIES (September 6, 1996)
  • K955713 — NOBELPHARMA BONE ANCHORED HEARING AID (August 9, 1996)
  • K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE (July 22, 1996)
  • K961736 — 17 ANGULATED ABUTMENT (July 18, 1996)
  • K961728 — MIRUSCONE ABUTMENT SYSTEM (July 10, 1996)
  • K961737 — CERA ONE ABUTMENT SYSTEM (July 10, 1996)
  • K960639 — ABUTMENT SELECTION KIT (May 14, 1996)
  • K955697 — ABUTMENT RETRIEVAL KIT (January 30, 1996)
  • K955372 — BALL ATTACHMENT SYSTEM (January 23, 1996)

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