FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONFORMA
K Number: K841559
·
Decision Jul 17, 1984
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
16
Applicant Total
45
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CONFORMA
- K Number
- K841559
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Beiersdorf, Inc.
- Date Received
- April 16, 1984
- Decision Date
- July 17, 1984
- Product Code
- GBI
- 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 |
|---|---|---|---|
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBI), ordered by most recent decision date.
FACTOR II PROSTHETIC SILICONE ELASTOMER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AHH NATURAL BREAST FORM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AMOENA BREAST FORMS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AMOENA BREAST FORMS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Beiersdorf, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Dec 18, 2009 | Substantially Equivalent |
| K024057 | CURAD SCAR THERAPY | Jun 18, 2003 | Substantially Equivalent |
| K952526 | CUTINOVA CAVITY | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K943363 | CUTIPLAST STERIL | Mar 15, 1995 | Substantially Equivalent |
| K944581 | CUTINOVA THIN WOUND DRESSING | Dec 2, 1994 | Substantially Equivalent for Some Indications |
| K935630 | NORTA | Oct 7, 1994 | Substantially Equivalent |
| K940378 | COVERLET ADHESIVE DRESSING | Jul 29, 1994 | Substantially Equivalent for Some Indications |
| K925630 | ELASTOPLAST HEAT PLASTER | Feb 25, 1994 | Substantially Equivalent |
| K926399 | CUTIFILM(R) FILM | Nov 15, 1993 | Substantially Equivalent |
| K923404 | LUEKOFLEX SURGICAL TAPE | Sep 9, 1992 | Substantially Equivalent |