The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Ias Disposable Pack.
Device ID | K853430 |
510k Number | K853430 |
Device Name: | STORZ IAS DISPOSABLE PACK |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Dan Regan |
Correspondent | Dan Regan 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 | 1985-08-15 |
Decision Date | 1985-12-16 |