OMNI COLD GEL PACKS
FDA 510(k) clearance K954877 · decided 1996-02-13
Clearance details
- K-number
- K954877
- Device name
- OMNI COLD GEL PACKS
- Applicant
- Omni Therm, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-10-24
- Decision date
- 1996-02-13
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- IMD
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.