DISPOSABLE MULTI-PUNCTURE APPLICATOR
FDA 510(k) clearance K922177 · decided 1993-06-17
Clearance details
- K-number
- K922177
- Device name
- DISPOSABLE MULTI-PUNCTURE APPLICATOR
- Applicant
- Allergy Extract Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-08
- Decision date
- 1993-06-17
- Days to decision
- 405 days
- Clearance type
- Traditional
- Product code
- SCL
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hilliard, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.