The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Midmark Procenter Instrument Delivery System.
| Device ID | K003090 |
| 510k Number | K003090 |
| Device Name: | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | MIDMARK CORP. OUTE 47 WEST, VISTA DR. Versailles, OH 45380 |
| Contact | Mike Snyder |
| Correspondent | Donald J Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2000-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709110184 | K003090 | 000 |
| 00841709122149 | K003090 | 000 |
| 00841709122156 | K003090 | 000 |
| 00841709122163 | K003090 | 000 |
| 00841709122170 | K003090 | 000 |
| 00841709118739 | K003090 | 000 |
| 00841709110139 | K003090 | 000 |
| 00841709110153 | K003090 | 000 |
| 00841709110160 | K003090 | 000 |
| 00841709110177 | K003090 | 000 |
| 00841709122132 | K003090 | 000 |