The following data is part of a premarket notification filed by Medical Safety Products, Inc. with the FDA for Acci-guard(tm) Regular And Pediatric Holder.
| Device ID | K884139 |
| 510k Number | K884139 |
| Device Name: | ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDICAL SAFETY PRODUCTS, INC. 2696 S. COLORADO BLVD., SUITE 585 Denver, CO 80222 |
| Contact | E Sagstetter |
| Correspondent | E Sagstetter MEDICAL SAFETY PRODUCTS, INC. 2696 S. COLORADO BLVD., SUITE 585 Denver, CO 80222 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1988-10-06 |