The following data is part of a premarket notification filed by Labotect Labor-technik Gottingen with the FDA for Ovarial Biopsy Set 324102-324108; Ovarial Biopsy Set 324200-324202; Ovarial Biopsy Needle 32218.
| Device ID | K003056 |
| 510k Number | K003056 |
| Device Name: | OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 |
| Classification | Needle, Assisted Reproduction |
| Applicant | LABOTECT LABOR-TECHNIK GOTTINGEN WILLI-EICHLER-STR. 25 Gottingen, DE D-37079 |
| Contact | Angelika Albrecht |
| Correspondent | Angelika Albrecht LABOTECT LABOR-TECHNIK GOTTINGEN WILLI-EICHLER-STR. 25 Gottingen, DE D-37079 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-01 |
| Decision Date | 2000-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046668003294 | K003056 | 000 |
| 04046668002266 | K003056 | 000 |
| 04046668002273 | K003056 | 000 |
| 04046668002280 | K003056 | 000 |
| 04046668002297 | K003056 | 000 |
| 04046668002310 | K003056 | 000 |
| 04046668002860 | K003056 | 000 |
| 04046668002877 | K003056 | 000 |
| 04046668002884 | K003056 | 000 |
| 04046668002945 | K003056 | 000 |
| 04046668002952 | K003056 | 000 |
| 04046668003072 | K003056 | 000 |
| 04046668003225 | K003056 | 000 |
| 04046668003270 | K003056 | 000 |
| 04046668003287 | K003056 | 000 |
| 04046668001481 | K003056 | 000 |