MODIFIED ADULT CRICOTHYROIDOTOMY KIT
FDA 510(k) clearance K885139 · decided 1989-05-25
Clearance details
- K-number
- K885139
- Device name
- MODIFIED ADULT CRICOTHYROIDOTOMY KIT
- Applicant
- Pertrach
- Decision
- Substantially Equivalent
- Date received
- 1988-12-15
- Decision date
- 1989-05-25
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bridgeport, WV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.