The following data is part of a premarket notification filed by Ansr Ent., Inc. with the FDA for Hypodermic Needle Sheath Holder.
Device ID | K882405 |
510k Number | K882405 |
Device Name: | HYPODERMIC NEEDLE SHEATH HOLDER |
Classification | Manometer, Spinal-fluid |
Applicant | ANSR ENT., INC. 1775 SOUTH TOMICHI FRANKTOWN, CO 80116 |
Contact | WAYNE R TURNER |
Correspondent | WAYNE R TURNER ANSR ENT., INC. 1775 SOUTH TOMICHI FRANKTOWN, CO 80116 |
Product Code | FMJ |
CFR Regulation Number | 880.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-10 |
Decision Date | 1988-06-29 |