FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUSHING BAYONET, INSULATED BIPOLAR FORCEP
K Number: K974595
·
Decision Jun 24, 1998
Classifications
1
FEI Numbers
658
Registration Numbers
658
Same Product Code
72
Applicant Total
3
Review Days
197
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Basic Information
- Device Name
- CUSHING BAYONET, INSULATED BIPOLAR FORCEP
- K Number
- K974595
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Titan Mfg., Inc.
- Date Received
- December 9, 1997
- Decision Date
- June 24, 1998
- Product Code
- HTD
- 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 |
|---|---|---|---|
| HTD | Forceps | FDA class 1 | General, Plastic Surgery |
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