The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Percutaneous Aspiration Biopsy (pab) Tray.
| Device ID | K870892 |
| 510k Number | K870892 |
| Device Name: | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Contact | Donna Collier |
| Correspondent | Donna Collier MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-05 |
| Decision Date | 1987-04-10 |