EMERGENCY ROOM PACK
FDA 510(k) clearance K850338 · decided 1985-03-25
Clearance details
- K-number
- K850338
- Device name
- EMERGENCY ROOM PACK
- Applicant
- Marwood Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-28
- Decision date
- 1985-03-25
- Days to decision
- 56 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Greensboro, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.