The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Plastic Surgery & Examination Lounge 7000.
Device ID | K845023 |
510k Number | K845023 |
Device Name: | STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 |
Classification | Table, Examination, Medical, Powered |
Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Contact | Tom Grant |
Correspondent | Tom Grant STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
Product Code | LGX |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-27 |
Decision Date | 1985-01-28 |