FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPENCIO SKIN GUARD KIT
K Number: K910927
·
Decision Jun 3, 1991
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
10
Review Days
90
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Basic Information
- Device Name
- SPENCIO SKIN GUARD KIT
- K Number
- K910927
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Spenco Medical Corp.
- Date Received
- March 5, 1991
- Decision Date
- June 3, 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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KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Spenco Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981902 | SPENCO SILICONE GEL SHEET | Jun 25, 1998 | Substantially Equivalent |
| K922228 | 2ND SKIN STERILE ADHESIVE STRIP | Dec 11, 1992 | Unknown |
| K911550 | 2ND SKIN MOIST BURN PADS WITH ALOE | Sep 6, 1991 | Substantially Equivalent |
| K896533 | SPENCO BREAST FORMS | Dec 13, 1989 | Substantially Equivalent |
| K894898 | 2ND SKIN NON-STICK MOIST BURN PADS | Aug 23, 1989 | Substantially Equivalent |
| K820906 | SPENCO CRYOPRESS | May 13, 1982 | Substantially Equivalent |
| K811184 | SPENCO DERMAL PADS | May 20, 1981 | Substantially Equivalent |
| K791726 | HYDROGEL-PREP | Nov 20, 1979 | Substantially Equivalent |
| K791162 | GELSKIN | Sep 4, 1979 | Substantially Equivalent |