ABELSON CRICOTHYROTOMY CANNULA
FDA 510(k) clearance K952401 · decided 1995-07-11
Clearance details
- K-number
- K952401
- Device name
- ABELSON CRICOTHYROTOMY CANNULA
- Applicant
- Gilbert Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-22
- Decision date
- 1995-07-11
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- BWC
- Device class
- 2
- Regulation number
- 868.5090
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bellmawr, NJ, US
- Third-party review
- No
- Expedited review
- No
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| 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE (K853345) | 31st. Centruy Medical Corp. | 1985-10-01 |
| WEISS EMERGENCY AIRWAY SYSTEM (K790650) | Intl. Medical Devices , Ltd. | 1979-06-27 |
Recalls involving this device
No recalls on record reference this clearance.