The following data is part of a premarket notification filed by Asap Endoscopic Products Gmbh with the FDA for Asap Hysteroscope And Gynecologic Laparoscope (surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0.
| Device ID | K031974 |
| 510k Number | K031974 |
| Device Name: | ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-26 |
| Decision Date | 2003-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G5921002930HD0 | K031974 | 000 |
| G5921002030HD0 | K031974 | 000 |