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510(k) K990458

STRAUMANN EXTRAORAL IMPLANT SYSTEM by Straumann USA — Product Code KCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1999
Date Received
February 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Breast, External, Used With Adhesive
Device Class
Class I
Regulation Number
878.3800
Review Panel
SU
Submission Type

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Other clearances for product code KCZ

  • K951324 — MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS (May 26, 1995)
  • K933465 — COSMET (July 20, 1994)
  • K932978 — CALSSIQUE OR MYSTIQUE (December 22, 1993)
  • K932899 — CLASSIQUE (December 16, 1993)
  • K933668 — ALMOST U, INC. BREAST PROSTHESIS (December 10, 1993)
  • K921535 — SUOENA AFFINITY (TM) MODEL #802 (May 11, 1992)
  • K915382 — AMOENA AFFINITY MODEL #802 (January 14, 1992)
  • K911247 — YOURS TRULY ASYMMETRICAL BREAST FORM (March 29, 1991)
  • K904085 — ELLA BREAST FORM (October 31, 1990)
  • K904316 — NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT (October 11, 1990)