The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Wescor Model 3700 Webster Sweat Inducer.
Device ID | K853973 |
510k Number | K853973 |
Device Name: | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER |
Classification | Device, Iontophoresis, Specific Uses |
Applicant | WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
Contact | Wayne K Barlow |
Correspondent | Wayne K Barlow WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
Product Code | KTB |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-26 |
Decision Date | 1985-10-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03661540303388 | K853973 | 000 |