FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
OSMO/PCA PILLOW WOUND DRESSING
K Number: K971612
·
Decision Mar 16, 1998
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
9
Review Days
318
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Basic Information
- Device Name
- OSMO/PCA PILLOW WOUND DRESSING
- K Number
- K971612
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Procyte Corp.
- Date Received
- May 2, 1997
- Decision Date
- March 16, 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 Procyte Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K972329 | OSMOCYTE RA WOUND DRESSING | Dec 10, 1997 | Substantially Equivalent for Some Indications |
| K972150 | OSMOCYTE ISLAND WOUND DRESSING | Dec 10, 1997 | Substantially Equivalent for Some Indications |
| K970153 | LAMIN-2 HYDRATING GEL | Jun 5, 1997 | Substantially Equivalent |
| K965143 | OSMOCYTE WOUND MANAGER SHEET DRESSING | May 22, 1997 | Substantially Equivalent |
| K965005 | IAMIN IMPREGNATED GAUZE DRESSING | Feb 24, 1997 | Substantially Equivalent |
| K964468 | IAMIN WET DRESSING (COPPER-SALINE) | Feb 3, 1997 | Substantially Equivalent |
| K962623 | OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING | Nov 26, 1996 | Substantially Equivalent |
| K953853 | IAMIN GEL WOUND DRESSING | Feb 5, 1996 | Substantially Equivalent for Some Indications |