The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Sinuscope And Accessories.
| Device ID | K981751 |
| 510k Number | K981751 |
| Device Name: | SINUSCOPE AND ACCESSORIES |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | HENKE SASS WOLF OF AMERICA, INC. 529 ASHLAND AVE. Southbridge, MA 01550 |
| Contact | Ellen J Henke |
| Correspondent | Ellen J Henke HENKE SASS WOLF OF AMERICA, INC. 529 ASHLAND AVE. Southbridge, MA 01550 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1998-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B351MY40000 | K981751 | 000 |
| G043BV40450 | K981751 | 000 |
| G043BV40300 | K981751 | 000 |
| G043BV40000 | K981751 | 000 |
| G043BV30700 | K981751 | 000 |
| G043BV30450 | K981751 | 000 |
| G043BV30300 | K981751 | 000 |
| G043BV30000 | K981751 | 000 |
| G043BV27700 | K981751 | 000 |
| G043BV27300 | K981751 | 000 |
| G043BV27000 | K981751 | 000 |
| 00857326005628 | K981751 | 000 |
| 00857326005611 | K981751 | 000 |
| 00857326005604 | K981751 | 000 |
| G043BV40700 | K981751 | 000 |
| B351MV40000 | K981751 | 000 |
| B351EE03000 | K981751 | 000 |
| B351MV40700 | K981751 | 000 |
| B351MV40450 | K981751 | 000 |
| B351MV40300 | K981751 | 000 |
| B351MV30700 | K981751 | 000 |
| B351MV30450 | K981751 | 000 |
| B351MV30300 | K981751 | 000 |
| B351MV30000 | K981751 | 000 |
| B351MV27700 | K981751 | 000 |
| B351MV27300 | K981751 | 000 |
| B351MV27000 | K981751 | 000 |
| B351EE03700 | K981751 | 000 |
| B351EE03450 | K981751 | 000 |
| B351EE03300 | K981751 | 000 |
| 00857326005598 | K981751 | 000 |