FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
YOURS TRULY ASYMMETRICAL BREAST FORM
K Number: K911247
·
Decision Mar 29, 1991
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
12
Applicant Total
15
Review Days
8
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Basic Information
- Device Name
- YOURS TRULY ASYMMETRICAL BREAST FORM
- K Number
- K911247
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Jobst Institute, Inc.
- Date Received
- March 21, 1991
- Decision Date
- March 29, 1991
- Product Code
- KCZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KCZ | Prosthesis, Breast, External, Used With Adhesive | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCZ), ordered by most recent decision date.
STRAUMANN EXTRAORAL IMPLANT SYSTEM
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MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS
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COSMET
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CALSSIQUE OR MYSTIQUE
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CLASSIQUE
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ALMOST U, INC. BREAST PROSTHESIS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Jobst Institute, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955138 | ANTI-EM/GP STOCKINGS | Dec 13, 1995 | Substantially Equivalent |
| K953763 | GLADIATOR ANTISHOCK PANTS | Nov 28, 1995 | Substantially Equivalent |
| K925583 | JOBSKIN CONTINUING CARE | Apr 4, 1994 | Substantially Equivalent |
| K925154 | JOBST-CUSTOM | Apr 4, 1994 | Substantially Equivalent |
| K934639 | JOBST ATHROMBIC PUMP - SYSTEM 2500 | Feb 9, 1994 | Substantially Equivalent |
| K922681 | CUTINOVA FOAM | Aug 31, 1992 | Substantially Equivalent |
| K921562 | JOBST EXTREMITY PUMP SYSTEM 7500 | Jun 22, 1992 | Substantially Equivalent |
| K920444 | ULTIMATE | Apr 20, 1992 | Substantially Equivalent |
| K912232 | ULCERCARE | Aug 14, 1991 | Substantially Equivalent |
| K905631 | COMPRINET, COMTESSE AND BELLAVAR STOCKINGS | Mar 7, 1991 | Substantially Equivalent |