The following data is part of a premarket notification filed by Pilling Weck Group with the FDA for Pilling Weck 2 Piece Take-apart Instruments.
| Device ID | K965176 |
| 510k Number | K965176 |
| Device Name: | PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| 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 | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-24 |
| Decision Date | 1997-03-04 |
| Summary: | summary |