FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
K Number: K961323
·
Decision Jun 19, 1996
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
27
Review Days
75
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Basic Information
- Device Name
- LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
- K Number
- K961323
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acme United Corp.
- Date Received
- April 5, 1996
- Decision Date
- June 19, 1996
- 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 Acme United Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING | May 31, 1996 | Substantially Equivalent |
| K952565 | LYOFOAM EXTRA | Nov 14, 1995 | Substantially Equivalent for Some Indications |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | Sep 10, 1990 | Substantially Equivalent for Some Indications |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Jun 9, 1987 | Substantially Equivalent |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | Nov 21, 1986 | Substantially Equivalent for Some Indications |
| K860085 | LYOFOAM WOUND DRESSINGS | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K860818 | ONE TIME ENTERAL FEEDING BAG | May 15, 1986 | Substantially Equivalent |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | Apr 22, 1986 | Substantially Equivalent |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | Aug 24, 1984 | Substantially Equivalent |
| K842064 | ACU-DERM TRANSPARENT IV DRESSING | Aug 15, 1984 | Substantially Equivalent |