STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
FDA 510(k) clearance K972367 · decided 1997-09-04
Clearance details
- K-number
- K972367
- Device name
- STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 1997-06-25
- Decision date
- 1997-09-04
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- KIJ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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