The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Dp4101 Basic I/a Pack.
Device ID | K953078 |
510k Number | K953078 |
Device Name: | STORZ DP4101 BASIC I/A PACK |
Classification | Unit, Phacofragmentation |
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 | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-03 |
Decision Date | 1995-08-07 |