The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Inc. Tuohy Epidural Needles.
Device ID | K150266 |
510k Number | K150266 |
Device Name: | Remington Medical Inc. Tuohy Epidural Needles |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta, GA 30005 |
Contact | Caitlin Senter |
Correspondent | Caitlin Senter REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta, GA 30005 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-04 |
Decision Date | 2015-06-04 |
Summary: | summary |