The following data is part of a premarket notification filed by Pilling Weck Group with the FDA for Reusable Trocar With Sleeve (common).
| Device ID | K964123 |
| 510k Number | K964123 |
| Device Name: | REUSABLE TROCAR WITH SLEEVE (COMMON) |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1996-12-12 |
| Summary: | summary |