The following data is part of a premarket notification filed by Pilling Weck, Inc. with the FDA for Burke Congenital Thoracoscopy Instruments.
| Device ID | K962771 |
| 510k Number | K962771 |
| Device Name: | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | PILLING WECK, INC. 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Richard G Jones |
| Correspondent | Richard G Jones PILLING WECK, INC. 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-16 |
| Decision Date | 1996-11-19 |
| Summary: | summary |