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510(k) K951324

MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS by Maxol Limited L.C. — Product Code KCZ

K951324 is an FDA 510(k) premarket notification submitted by Maxol Limited L.C. for the device "MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS". The FDA issued a decision of Substantially Equivalent on May 26, 1995. 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
May 26, 1995
Date Received
March 23, 1995
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

  • K990458 — STRAUMANN EXTRAORAL IMPLANT SYSTEM (April 16, 1999)
  • 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)

FDA data resources