The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz D7108 Microscissors Handpiece/storz D7106 Microscissors Drive Tube.
| Device ID | K960061 |
| 510k Number | K960061 |
| Device Name: | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen 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 | 1996-01-04 |
| Decision Date | 1996-09-18 |
| Summary: | summary |