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 |