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 |