OPERATING ROOM NEEDLE COUNTER
FDA 510(k) clearance K923512 · decided 1992-11-23
Clearance details
- K-number
- K923512
- Device name
- OPERATING ROOM NEEDLE COUNTER
- Applicant
- Sharp-Trap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-07
- Decision date
- 1992-11-23
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Southfield, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.