FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYPERGEL PROTECTIVE WOUND GEL
K Number: K905439
·
Decision May 29, 1991
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
9
Review Days
176
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Basic Information
- Device Name
- HYPERGEL PROTECTIVE WOUND GEL
- K Number
- K905439
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Scott Health Care
- Date Received
- December 4, 1990
- Decision Date
- May 29, 1991
- 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 Scott Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K954275 | MEPORE PLUS (9X15CM) | Dec 27, 1995 | Substantially Equivalent |
| K954274 | MEPORE (6X7) | Dec 19, 1995 | Substantially Equivalent |
| K945206 | ALLDRESS MULTI LAYERED WOUND DRESSING | Jan 12, 1995 | Substantially Equivalent |
| K932743 | MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION | Sep 10, 1993 | Substantially Equivalent |
| K910857 | ALLDRESS MULTI LAYERED WOUND DRESSING | Apr 12, 1991 | Substantially Equivalent |
| K905438 | NORMLGEL PROTECTIVE WOUND GEL | Apr 1, 1991 | Substantially Equivalent |
| K900421 | PROMISE ABSORBENT PROTECTIVE PAD | Jun 6, 1990 | Substantially Equivalent |
| K897142 | MESALT STERILE DRESSING | Mar 27, 1990 | Substantially Equivalent |