FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRAITH CHISEL FORCEPS
K Number: K801075
·
Decision May 20, 1980
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
103
Applicant Total
12
Review Days
14
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Basic Information
- Device Name
- STRAITH CHISEL FORCEPS
- K Number
- K801075
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgical Technology Laboratories, Inc.
- Date Received
- May 6, 1980
- Decision Date
- May 20, 1980
- Product Code
- GEN
- 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 |
|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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| K964443 | SURGIFORM ANATOMICAL MALAR | Dec 20, 1996 | Substantially Equivalent |
| K840835 | STRAITH DRAIN INSERTER | Apr 23, 1984 | Substantially Equivalent |
| K831078 | STRAITH ORAL AIRWAY | Jun 24, 1983 | Substantially Equivalent |
| K801072 | STRAITH NASAL SPLINT | Jun 17, 1980 | Substantially Equivalent |
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