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510(k) K921535

SUOENA AFFINITY (TM) MODEL #802 by Coloplast Corp. — Product Code KCZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1992
Date Received
March 31, 1992
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

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  • K932978 — CALSSIQUE OR MYSTIQUE (December 22, 1993)
  • K932899 — CLASSIQUE (December 16, 1993)
  • K933668 — ALMOST U, INC. BREAST PROSTHESIS (December 10, 1993)
  • K915382 — AMOENA AFFINITY MODEL #802 (January 14, 1992)
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  • K904085 — ELLA BREAST FORM (October 31, 1990)
  • K904316 — NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT (October 11, 1990)