The following data is part of a premarket notification filed by Pilling Weck Group with the FDA for Secondary Trocar And Sleeve With Insufflation Port.
| Device ID | K964450 |
| 510k Number | K964450 |
| Device Name: | SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | PILLING WECK GROUP TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Karenann J Brozowski |
| Correspondent | Karenann J Brozowski PILLING WECK GROUP TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1997-01-10 |
| Summary: | summary |