ASLI
FDA 510(k) clearance K973473 · decided 1997-09-26
Clearance details
- K-number
- K973473
- Device name
- ASLI
- Applicant
- Texin Industrial (International) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-15
- Decision date
- 1997-09-26
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Vancouver, Bc, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.