The following data is part of a premarket notification filed by Conair Corp. with the FDA for Infraderm; Touch 'n Tone Plus.
Device ID | K911727 |
510k Number | K911727 |
Device Name: | INFRADERM; TOUCH 'N TONE PLUS |
Classification | Massager, Therapeutic, Electric |
Applicant | CONAIR CORP. 1 CUMMINGS POINT RD. Stamford, CT 06904 |
Contact | James H Bennett |
Correspondent | James H Bennett CONAIR CORP. 1 CUMMINGS POINT RD. Stamford, CT 06904 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-17 |
Decision Date | 1994-02-25 |