The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Dp5100 Anterior Collection Cassette Pack.
Device ID | K961874 |
510k Number | K961874 |
Device Name: | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK |
Classification | Unit, Phacofragmentation |
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 | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-15 |
Decision Date | 1996-08-06 |
Summary: | summary |