ORTHO TECH CRYOLOGIC SYSTEM
FDA 510(k) clearance K940429 · decided 1994-07-12
Clearance details
- K-number
- K940429
- Device name
- ORTHO TECH CRYOLOGIC SYSTEM
- Applicant
- Orthopedic Technology, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-01-31
- Decision date
- 1994-07-12
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- ILO
- Device class
- 2
- Regulation number
- 890.5720
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Tracy, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.