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510(k) K933668

ALMOST U, INC. BREAST PROSTHESIS by Almost U., Inc. — Product Code KCZ

K933668 is an FDA 510(k) premarket notification submitted by Almost U., Inc. for the device "ALMOST U, INC. BREAST PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 10, 1993. The device falls under product code KCZ (Prosthesis, Breast, External, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1993
Date Received
July 28, 1993
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

Other clearances for product code KCZ

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  • 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)
  • 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)

FDA data resources