The following data is part of a premarket notification filed by Holl Meditronics, Inc. with the FDA for Arco-mbc, Arco Mc.
| Device ID | K954171 |
| 510k Number | K954171 |
| Device Name: | ARCO-MBC, ARCO MC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HOLL MEDITRONICS, INC. 4 MARCONI COURT Bolton, Ontario, CA L7e 1e7 |
| Contact | William H Holl |
| Correspondent | William H Holl HOLL MEDITRONICS, INC. 4 MARCONI COURT Bolton, Ontario, CA L7e 1e7 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1996-04-30 |