The following data is part of a premarket notification filed by Vectec with the FDA for Vectec Disposable Pneumoperitoneum Needle.
| Device ID | K121370 |
| 510k Number | K121370 |
| Device Name: | VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE |
| Classification | Pneumoperitoneum Needle |
| Applicant | VECTEC 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Contact | Diane Horwitz |
| Correspondent | Diane Horwitz VECTEC 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Product Code | FHO |
| Subsequent Product Code | FHP |
| Subsequent Product Code | HIF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2013-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700393300639 | K121370 | 000 |
| 03700393300615 | K121370 | 000 |