The following data is part of a premarket notification filed by Dermacare Products, Inc. with the FDA for Infant Electrosurgical Dispersive Electrode.
Device ID | K882421 |
510k Number | K882421 |
Device Name: | INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE |
Classification | Electrode, Electrosurgical |
Applicant | DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
Contact | Ken Potts |
Correspondent | Ken Potts DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214 |
Product Code | JOS |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-13 |
Decision Date | 1988-06-30 |