The following data is part of a premarket notification filed by Beech Medical Products, Inc. with the FDA for Selfshield Hn Self Sheathing Hypodermic Needle.
| Device ID | K972469 |
| 510k Number | K972469 |
| Device Name: | SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BEECH MEDICAL PRODUCTS, INC. 241 LACKLAND DR. Middlesex, NJ 08846 |
| Contact | John Romano |
| Correspondent | John Romano BEECH MEDICAL PRODUCTS, INC. 241 LACKLAND DR. Middlesex, NJ 08846 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-08-27 |
| Summary: | summary |