The following data is part of a premarket notification filed by Pilling Weck Group with the FDA for Pilling Weck Secondary Flexible Sleeve With Trocar.
| Device ID | K971334 |
| 510k Number | K971334 |
| Device Name: | PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR |
| 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 | 1997-04-10 |
| Decision Date | 1997-06-11 |
| Summary: | summary |