The following data is part of a premarket notification filed by Herbert Stanley Co. with the FDA for Ultrasonic Transmission Gel.
Device ID | K884503 |
510k Number | K884503 |
Device Name: | ULTRASONIC TRANSMISSION GEL |
Classification | Electrode, Gel, Electrosurgical |
Applicant | HERBERT STANLEY CO. 8140 N. RIDGEWAY Skokie, IL 60076 |
Contact | B Demasi |
Correspondent | B Demasi HERBERT STANLEY CO. 8140 N. RIDGEWAY Skokie, IL 60076 |
Product Code | JOT |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-25 |
Decision Date | 1989-02-13 |