The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Photostress Recovery Tester.
Device ID | K933814 |
510k Number | K933814 |
Device Name: | PHOTOSTRESS RECOVERY TESTER |
Classification | Electrode, Cutaneous |
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 | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-04 |
Decision Date | 1993-12-08 |