The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Mrl Pacette, 450sll.
| Device ID | K880932 |
| 510k Number | K880932 |
| Device Name: | MRL PACETTE, 450SLL |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | MEDICAL RESEARCH LABORATORIES, INC. 6457 W. HOWARD ST. Niles, IL 60648 |
| Contact | Dilip Mehta |
| Correspondent | Dilip Mehta MEDICAL RESEARCH LABORATORIES, INC. 6457 W. HOWARD ST. Niles, IL 60648 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-12-16 |