The following data is part of a premarket notification filed by Val Med Corp. with the FDA for Nurse's Assistant O.r. Control System.
| Device ID | K010754 |
| 510k Number | K010754 |
| Device Name: | NURSE'S ASSISTANT O.R. CONTROL SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VAL MED CORP. 555 THIRTEENTH ST. N.W. COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Howard M Holstein, Esq. |
| Correspondent | Howard M Holstein, Esq. VAL MED CORP. 555 THIRTEENTH ST. N.W. COLUMBIA SQUARE Washington, DC 20004 |
| Product Code | GCJ |
| Subsequent Product Code | FET |
| Subsequent Product Code | FSY |
| Subsequent Product Code | HET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2001-08-15 |
| Summary: | summary |