510(k) K070596
- Device
- TOPICAL APPLICATOR
- Applicant
- SHARN, INC.
- 510(k) number
- K070596
- Product code
- CCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-21
- Date received
- 2007-03-02
- Regulation
- 868.5170
- Classification name
- Applicator (laryngo-tracheal), Topical Anesthesia
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL DRYDEN
- Address
- 3460 Pt.e Creek Ct. #102 Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 3003898360
- 3034654861
- 1832562
- 3011137372
- 3020460367
Source Documents#
Other 510(k) Records For Product Code CCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240114 | UltraEzAir® (UEA1A) | Dualams, Inc., Dba Airkor | 2024-10-16 |
| K172956 | Medicant Mucosal Atomizer | Medica Holdings, LLC | 2018-04-06 |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Teleflex Medical | 2016-08-19 |
| K093584 | EZ-MISTER | N.M. Beale Co., Inc. | 2011-03-04 |
| K002255 | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) | Wolfe Tory Medical, Inc. | 2000-09-18 |
| K894755 | ASTRA DISPOSABLE SPRAY CANNULA | Astra Pharmaceutical Products, Inc. | 1990-01-12 |
| K810059 | ENDO-MED TUBE FOR ENDOTRACHEAL MED | Ackrad Laboratories | 1981-02-26 |
| K760759 | ANESTHESIA KIT | Sherwood Medical Industries | 1976-12-09 |
| K760877 | MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT | Sherwood Medical Industries | 1976-12-09 |
Legacy Summary#
summary
FDA Review#
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