The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz N5941 Series Medical Grade Tubing.
| Device ID | K940352 |
| 510k Number | K940352 |
| Device Name: | STORZ N5941 SERIES MEDICAL GRADE TUBING |
| Classification | Catheter, Irrigation |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Michael H Southworth |
| Correspondent | Michael H Southworth STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-04-14 |