FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
MODIFICATION TO SKVEKPATCH
K Number: K984177
·
Decision Dec 18, 1998
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- MODIFICATION TO SKVEKPATCH
- K Number
- K984177
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Marine Polymer Technologies, Inc.
- Date Received
- November 20, 1998
- Decision Date
- December 18, 1998
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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Other Clearances by Marine Polymer Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160695 | Talymed Suspension | Dec 6, 2016 | Substantially Equivalent |
| K111524 | MP 719 | Jul 22, 2011 | Substantially Equivalent |
| K082703 | MRDH BANDAGE | Oct 14, 2008 | Substantially Equivalent |
| K070557 | MP 719 | May 23, 2007 | Substantially Equivalent |
| K053300 | SYVEKEXCEL | Mar 28, 2006 | Substantially Equivalent |
| K002550 | RDH BANDAGE | Dec 20, 2000 | Substantially Equivalent |
| K972914 | SYVEK PATCH | Dec 22, 1997 | Substantially Equivalent |