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510(k) K911247

YOURS TRULY ASYMMETRICAL BREAST FORM by Jobst Institute, Inc. — Product Code KCZ

K911247 is an FDA 510(k) premarket notification submitted by Jobst Institute, Inc. for the device "YOURS TRULY ASYMMETRICAL BREAST FORM". The FDA issued a decision of Substantially Equivalent on March 29, 1991. The device falls under product code KCZ (Prosthesis, Breast, External, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Jobst Institute, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
March 21, 1991
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 by Jobst Institute, Inc.

  • K955138 — ANTI-EM/GP STOCKINGS (December 13, 1995)
  • K953763 — GLADIATOR ANTISHOCK PANTS (November 28, 1995)
  • K925154 — JOBST-CUSTOM (April 4, 1994)
  • K925583 — JOBSKIN CONTINUING CARE (April 4, 1994)
  • K934639 — JOBST ATHROMBIC PUMP - SYSTEM 2500 (February 9, 1994)
  • K922681 — CUTINOVA FOAM (August 31, 1992)
  • K921562 — JOBST EXTREMITY PUMP SYSTEM 7500 (June 22, 1992)
  • K920444 — ULTIMATE (April 20, 1992)
  • K912232 — ULCERCARE (August 14, 1991)
  • K905631 — COMPRINET, COMTESSE AND BELLAVAR STOCKINGS (March 7, 1991)

Other clearances for product code KCZ

  • K990458 — STRAUMANN EXTRAORAL IMPLANT SYSTEM (April 16, 1999)
  • 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)
  • K904085 — ELLA BREAST FORM (October 31, 1990)
  • K904316 — NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT (October 11, 1990)

FDA data resources