SURVIVAL KIT, INDIVIDUAL
FDA 510(k) clearance K871437 · decided 1987-07-09
Clearance details
- K-number
- K871437
- Device name
- SURVIVAL KIT, INDIVIDUAL
- Applicant
- Fraass Survival Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-13
- Decision date
- 1987-07-09
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- LRO
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bronx, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.