The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Control-tip Cystoscopic Electrodes.
| Device ID | K903156 |
| 510k Number | K903156 |
| Device Name: | CONTROL-TIP CYSTOSCOPIC ELECTRODES |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Contact | Harry Schlakman |
| Correspondent | Harry Schlakman NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-18 |
| Decision Date | 1990-12-18 |