The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Greene Needle.
Device ID | K885145 |
510k Number | K885145 |
Device Name: | MEDSURG GREENE NEEDLE |
Classification | Needle, Biopsy, Cardiovascular |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Thomas Bonner |
Correspondent | Thomas Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | DWO |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-15 |
Decision Date | 1989-03-14 |