FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPENCO DERMAL PADS
K Number: K811184
·
Decision May 20, 1981
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
10
Review Days
21
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Basic Information
- Device Name
- SPENCO DERMAL PADS
- K Number
- K811184
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Spenco Medical Corp.
- Date Received
- April 29, 1981
- Decision Date
- May 20, 1981
- Product Code
- FMP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | FDA class 1 | General Hospital |
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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 |
| K910927 | SPENCIO SKIN GUARD KIT | Jun 3, 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 |
| K791726 | HYDROGEL-PREP | Nov 20, 1979 | Substantially Equivalent |
| K791162 | GELSKIN | Sep 4, 1979 | Substantially Equivalent |