The following data is part of a premarket notification filed by Asap Endoscopic Products Gmbh with the FDA for Asap Sinuscope 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0.
| Device ID | K032822 |
| 510k Number | K032822 |
| Device Name: | ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | ASAP ENDOSCOPIC PRODUCTS GMBH KATHARINENSTR. 5 Luebeck, DE 23554 |
| Contact | Martina Guenderoth |
| Correspondent | Martina Guenderoth ASAP ENDOSCOPIC PRODUCTS GMBH KATHARINENSTR. 5 Luebeck, DE 23554 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-10 |
| Decision Date | 2004-01-08 |
| Summary: | summary |