The following data is part of a premarket notification filed by Medical Hospital Equipment with the FDA for R.r. Aghi Hypodermic Single Lumen Needle.
| Device ID | K852615 |
| 510k Number | K852615 |
| Device Name: | R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDICAL HOSPITAL EQUIPMENT 236 THIRD AVENUE, SUITE A Chula Vista, CA 92010 |
| Contact | Maruca, J |
| Correspondent | Maruca, J MEDICAL HOSPITAL EQUIPMENT 236 THIRD AVENUE, SUITE A Chula Vista, CA 92010 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1986-03-21 |