The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Seldinger Needle.
Device ID | K854294 |
510k Number | K854294 |
Device Name: | MEDSURG SELDINGER NEEDLE |
Classification | Trocar |
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 | DRC |
CFR Regulation Number | 870.1390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-10-25 |
Decision Date | 1986-01-13 |