The following data is part of a premarket notification filed by Alphamed Inc. with the FDA for Alphamed Surgical Spear, Model 70-5000.
| Device ID | K091240 |
| 510k Number | K091240 |
| Device Name: | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 |
| Classification | Sponge, Ophthalmic |
| Applicant | ALPHAMED INC. 3912 MOUNTAIN AVE. El Paso, TX 79930 |
| Contact | James Gubachy |
| Correspondent | James Gubachy ALPHAMED INC. 3912 MOUNTAIN AVE. El Paso, TX 79930 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-10-23 |