The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Ent/ophthalmic Maxi Chair.
Device ID | K870112 |
510k Number | K870112 |
Device Name: | STORZ ENT/OPHTHALMIC MAXI CHAIR |
Classification | Chair, Ophthalmic, 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 | HME |
CFR Regulation Number | 886.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-12 |
Decision Date | 1987-02-12 |