The following data is part of a premarket notification filed by North American Sterilization & Packaging Co. with the FDA for Nortec Sterile Water For Catheter Balloon Inflatio.
| Device ID | K925161 |
| 510k Number | K925161 |
| Device Name: | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO |
| Classification | Accessories, Catheter, G-u |
| Applicant | NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Contact | Charles E Meisch |
| Correspondent | Charles E Meisch NORTH AMERICAN STERILIZATION & PACKAGING CO. 15 WHITE LAKE RD. P.O. BOX 923 Sparta, NJ 07871 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-07-21 |