The following data is part of a premarket notification filed by Medco Products, Co., Inc. with the FDA for Skull Mounted Stereotactic Surgical Device.
| Device ID | K851659 |
| 510k Number | K851659 |
| Device Name: | SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDCO PRODUCTS, CO., INC. 96 FAIR ST. Cooperstown, NY 13326 |
| Contact | Mark Carol |
| Correspondent | Mark Carol MEDCO PRODUCTS, CO., INC. 96 FAIR ST. Cooperstown, NY 13326 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-07-01 |