MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT
FDA 510(k) clearance K862335 · decided 1986-07-24
Clearance details
- K-number
- K862335
- Device name
- MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT
- Applicant
- U.S. Mfg. & Management, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1986-06-19
- Decision date
- 1986-07-24
- Days to decision
- 35 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- San Bernardino, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.