INSTANT ICE PACK
FDA 510(k) clearance K901834 · decided 1990-05-03
Clearance details
- K-number
- K901834
- Device name
- INSTANT ICE PACK
- Applicant
- Impact Packaging Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-24
- Decision date
- 1990-05-03
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- IMD
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.