The following data is part of a premarket notification filed by Stortz with the FDA for Maxi Cabinet Optional Built In S6000 Light Source.
Device ID | K911901 |
510k Number | K911901 |
Device Name: | MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE |
Classification | Unit, Examining/treatment, Ent |
Applicant | STORTZ 3365 TREE COURT IND.BLVD St.louis, MO 63122 |
Contact | Michael T.taggert |
Correspondent | Michael T.taggert STORTZ 3365 TREE COURT IND.BLVD St.louis, MO 63122 |
Product Code | ETF |
CFR Regulation Number | 874.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-29 |
Decision Date | 1991-07-26 |