The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Chiba Ptc Needle.
Device ID | K870893 |
510k Number | K870893 |
Device Name: | MEDSURG CHIBA PTC NEEDLE |
Classification | Needle, Aspiration And Injection, Disposable |
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 | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-05 |
Decision Date | 1987-03-25 |