FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLAMP COVERS
K Number: K790952
·
Decision Jun 5, 1979
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
8
Review Days
14
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Basic Information
- Device Name
- CLAMP COVERS
- K Number
- K790952
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medi-Spec
- Date Received
- May 22, 1979
- Decision Date
- June 5, 1979
- Product Code
- GAD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Medi-Spec
| K Number | Device Name | ||
|---|---|---|---|
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Feb 4, 1984 | Substantially Equivalent |
| K812694 | WHISK-R | Oct 26, 1981 | Substantially Equivalent |
| K812426 | UTERINE ASPIRATION CURETTES(RIGID&FLEX) | Oct 8, 1981 | Substantially Equivalent |
| K801554 | STERILE CAST PADDING | Aug 4, 1980 | Substantially Equivalent |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Apr 24, 1980 | Substantially Equivalent |
| K800490 | STERILE DRESSING PACK | Mar 12, 1980 | Substantially Equivalent |
| K780548 | DISPOSA-LOOPS | Aug 21, 1978 | Substantially Equivalent |