The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for D7113 Anvil Cutter And D7112 Air-powered Handle.
| Device ID | K915745 |
| 510k Number | K915745 |
| Device Name: | D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Janet Lacavich |
| Correspondent | Janet Lacavich STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-23 |
| Decision Date | 1992-03-13 |