The following data is part of a premarket notification filed by Modular Cutting Systems, Inc. with the FDA for Avcore System.
| Device ID | K990816 |
| 510k Number | K990816 |
| Device Name: | AVCORE SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | MODULAR CUTTING SYSTEMS, INC. 650 CLINTON AVE. Bridgeport, CT 06605 |
| Contact | Allen P Schlein |
| Correspondent | Allen P Schlein MODULAR CUTTING SYSTEMS, INC. 650 CLINTON AVE. Bridgeport, CT 06605 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-11 |
| Decision Date | 1999-09-24 |
| Summary: | summary |