The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Henke Sass Wolf Of America Nasopharyngoscope.
| Device ID | K030572 |
| 510k Number | K030572 |
| Device Name: | HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | HENKE SASS WOLF OF AMERICA, INC. 203 MAIN STREET, PMB 166 Flemington, NJ 08822 |
| Contact | Lynette Howard |
| Correspondent | Lynette Howard HENKE SASS WOLF OF AMERICA, INC. 203 MAIN STREET, PMB 166 Flemington, NJ 08822 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-24 |
| Decision Date | 2003-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B366FE102R000 | K030572 | 000 |
| B366SN102 | K030572 | 000 |
| B366SN104 | K030572 | 000 |
| B366SN105 | K030572 | 000 |
| B366SN106 | K030572 | 000 |
| B366SN108 | K030572 | 000 |
| B366SN109 | K030572 | 000 |
| B366SN110 | K030572 | 000 |
| B366SN113 | K030572 | 000 |
| B366SN114 | K030572 | 000 |
| B366SN115 | K030572 | 000 |
| B366SN116 | K030572 | 000 |
| B366SN117 | K030572 | 000 |
| B351MV10000 | K030572 | 000 |
| B351MV10340 | K030572 | 000 |
| B366SN101 | K030572 | 000 |