The following data is part of a premarket notification filed by Topical Testing, Inc. with the FDA for Vibrotactile Tester, Model No. Vtt-100.
Device ID | K921560 |
510k Number | K921560 |
Device Name: | VIBROTACTILE TESTER, MODEL NO. VTT-100 |
Classification | Device, Vibration Threshold Measurement |
Applicant | TOPICAL TESTING, INC. 1308 SOUTH 1700 EAST, #209 Salt Lake City, UT 84108 |
Contact | Robert P Tuckett |
Correspondent | Robert P Tuckett TOPICAL TESTING, INC. 1308 SOUTH 1700 EAST, #209 Salt Lake City, UT 84108 |
Product Code | LLN |
CFR Regulation Number | 882.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-01 |
Decision Date | 1992-10-30 |