The following data is part of a premarket notification filed by Medco Products, Co., Inc. with the FDA for Medcolator Model Hvx.
| Device ID | K844580 |
| 510k Number | K844580 |
| Device Name: | MEDCOLATOR MODEL HVX |
| Classification | Stimulator, Muscle, Powered |
| Applicant | MEDCO PRODUCTS, CO., INC. 31 PARK RD. P.O. BOX E Tinton Falls, NJ 07724 |
| Contact | Richard N Lord |
| Correspondent | Richard N Lord MEDCO PRODUCTS, CO., INC. 31 PARK RD. P.O. BOX E Tinton Falls, NJ 07724 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-23 |
| Decision Date | 1985-02-25 |