FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
K Number: K984539
·
Decision Mar 1, 1999
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
20
Review Days
70
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Basic Information
- Device Name
- FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
- K Number
- K984539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ferris Mfg. Corp.
- Date Received
- December 21, 1998
- Decision Date
- March 1, 1999
- 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 Ferris Mfg. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K031660 | FERRIS POLYMEM STERILE BREAST PAD | Feb 22, 2005 | Substantially Equivalent |
| K031307 | FERRIS POLYMEM SILVER WOUND DRESSING | Oct 22, 2003 | Substantially Equivalent |
| K002129 | FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN | Aug 25, 2000 | Substantially Equivalent |
| K991729 | FERRIS POLYOSTOMY STERILE WOUND DRESSING | Aug 27, 1999 | Substantially Equivalent |
| K990906 | FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER | Apr 29, 1999 | Substantially Equivalent for Some Indications |
| K982306 | POLYTUBE | Sep 22, 1998 | Substantially Equivalent |
| K932913 | FERRIS POLYMEM HYDROPHILIC WOUND DRESSING | Jun 7, 1994 | Substantially Equivalent for Some Indications |
| K900127 | FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) | May 18, 1990 | Substantially Equivalent for Some Indications |
| K880330 | FERRIS HYDROPHILIC DRESSING | Mar 23, 1988 | Substantially Equivalent for Some Indications |
| K874478 | DYNAFILM | Jan 14, 1988 | Substantially Equivalent for Some Indications |