The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Ad-tech's Depth Electrode.
Device ID | K891920 |
510k Number | K891920 |
Device Name: | AD-TECH'S DEPTH ELECTRODE |
Classification | Electrode, Depth |
Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
Contact | Anthony Putz |
Correspondent | Anthony Putz AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
Product Code | GZL |
CFR Regulation Number | 882.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-27 |
Decision Date | 1989-07-27 |