FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Talymed Suspension
K Number: K160695
·
Decision Dec 6, 2016
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
8
Review Days
267
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Basic Information
- Device Name
- Talymed Suspension
- K Number
- K160695
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Marine Polymer Technologies, Inc.
- Date Received
- March 14, 2016
- Decision Date
- December 6, 2016
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Marine Polymer Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K984177 | MODIFICATION TO SKVEKPATCH | Dec 18, 1998 | Substantially Equivalent for Some Indications |
| K972914 | SYVEK PATCH | Dec 22, 1997 | Substantially Equivalent |