EZ-MISTER
FDA 510(k) clearance K093584 · decided 2011-03-04
Clearance details
- K-number
- K093584
- Device name
- EZ-MISTER
- Applicant
- N.M. Beale Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-19
- Decision date
- 2011-03-04
- Days to decision
- 470 days
- Clearance type
- Traditional
- Product code
- CCT
- Device class
- 2
- Regulation number
- 868.5170
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ayer, MA, US
- Third-party review
- No
- Expedited review
- No
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| ASTRA DISPOSABLE SPRAY CANNULA (K894755) | Astra Pharmaceutical Products, Inc. | 1990-01-12 |
| ENDO-MED TUBE FOR ENDOTRACHEAL MED (K810059) | Ackrad Laboratories | 1981-02-26 |
| ANESTHESIA KIT (K760759) | Sherwood Medical Industries | 1976-12-09 |
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Recalls involving this device
No recalls on record reference this clearance.