FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELASTOPLAST HEAT PLASTER
K Number: K925630
·
Decision Feb 25, 1994
Classifications
1
FEI Numbers
259
Registration Numbers
259
Same Product Code
41
Applicant Total
45
Review Days
476
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Basic Information
- Device Name
- ELASTOPLAST HEAT PLASTER
- K Number
- K925630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5740
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beiersdorf, Inc.
- Date Received
- November 6, 1992
- Decision Date
- February 25, 1994
- Product Code
- IRT
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IRT | Pad, Heating, Powered | FDA class 2 | Physical Medicine |
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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 |
| K926399 | CUTIFILM(R) FILM | Nov 15, 1993 | Substantially Equivalent |
| K923404 | LUEKOFLEX SURGICAL TAPE | Sep 9, 1992 | Substantially Equivalent |
| K921759 | ACRYLASTIC | Aug 10, 1992 | Substantially Equivalent |