The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Endoscopes And Accessories.
| Device ID | K950612 |
| 510k Number | K950612 |
| Device Name: | ENDOSCOPES AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-10 |
| Decision Date | 1995-04-25 |