FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRILL, CORDLESS SURGICAL
K Number: K790063
·
Decision Feb 5, 1979
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
48
Review Days
21
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Basic Information
- Device Name
- DRILL, CORDLESS SURGICAL
- K Number
- K790063
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Richard'S Medical Equip., Inc.
- Date Received
- January 15, 1979
- Decision Date
- February 5, 1979
- Product Code
- KIJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Richard'S Medical Equip., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC | Jun 16, 1983 | Substantially Equivalent |
| K823837 | RMC TOTAL KNEE SYSTEM | Mar 29, 1983 | Substantially Equivalent |
| K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP | Mar 9, 1983 | Substantially Equivalent |
| K823724 | SPECTRON NECK REPLACEMENT PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823723 | SPECTRON PROXIMAL FEMORAL PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823722 | SPECTRON LONG, STRAIGHT FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K823727 | SPECTRON PRIMARY STEM FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K830153 | RICHARDS INTRA-ARTICULAR SHAVER BLADES | Feb 28, 1983 | Substantially Equivalent |
| K830154 | COLLES FRACTURE FRAME | Feb 2, 1983 | Substantially Equivalent |
| K823725 | SPECTRON PROTRUSIO CUP | Jan 21, 1983 | Substantially Equivalent |