The following data is part of a premarket notification filed by Sharn, Inc. with the FDA for Topical Applicator.
| Device ID | K070596 |
| 510k Number | K070596 |
| Device Name: | TOPICAL APPLICATOR |
| Classification | Applicator (laryngo-tracheal), Topical Anesthesia |
| Applicant | SHARN, INC. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden SHARN, INC. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Product Code | CCT |
| CFR Regulation Number | 868.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-02 |
| Decision Date | 2007-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841470103825 | K070596 | 000 |
| 10841470103818 | K070596 | 000 |
| 10841470103801 | K070596 | 000 |
| 10841470100336 | K070596 | 000 |
| 10841470100329 | K070596 | 000 |
| 10841470100312 | K070596 | 000 |