The following data is part of a premarket notification filed by Asap Endoscopic Products Gmbh with the FDA for Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope.
| Device ID | K031141 |
| 510k Number | K031141 |
| Device Name: | ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | ASAP ENDOSCOPIC PRODUCTS GMBH KATHARINENSTR. 5 Luebeck, DE 23554 |
| Contact | Martina Gunderoth |
| Correspondent | Martina Gunderoth ASAP ENDOSCOPIC PRODUCTS GMBH KATHARINENSTR. 5 Luebeck, DE 23554 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-10 |
| Decision Date | 2003-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G592951030HD0 | K031141 | 000 |
| G592951000HD0 | K031141 | 000 |
| G592950530HD0 | K031141 | 000 |
| G592950500HD0 | K031141 | 000 |
| G5922000430HD0 | K031141 | 000 |