FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUTTER, P607 BONE
K Number: K770305
·
Decision Mar 9, 1977
Classifications
1
FEI Numbers
257
Registration Numbers
257
Same Product Code
51
Applicant Total
9
Review Days
21
Basic Information
- Device Name
- CUTTER, P607 BONE
- K Number
- K770305
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- DENTRONIX INC.
- Date Received
- February 16, 1977
- Decision Date
- March 9, 1977
- Product Code
- FZT
- 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 |
|---|---|---|---|
| FZT | Cutter, Surgical | FDA class 1 | General, Plastic Surgery |
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Other Clearances by DENTRONIX INC.
| K Number | Device Name | ||
|---|---|---|---|
| K910202 | DENTRONIX MODEL 2000 | Mar 13, 1991 | Substantially Equivalent |
| K880322 | DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM | Jul 13, 1988 | Substantially Equivalent |
| K771005 | NEW PODIATRY PRODUCTS | Jun 17, 1977 | Substantially Equivalent |
| K771006 | MODIFIED PODIATRY PRODUCTS | Jun 17, 1977 | Substantially Equivalent |
| K770302 | CUTTER, P606 BONE | Mar 9, 1977 | Substantially Equivalent |
| K770304 | CUTTER, P605 GENERAL PURPOSE | Mar 9, 1977 | Substantially Equivalent |
| K770303 | NIPPER, NAIL, P610 ENGLISH | Mar 9, 1977 | Substantially Equivalent |
| K770301 | NIPPER, PSO4 TISSUE | Mar 7, 1977 | Substantially Equivalent |