The following data is part of a premarket notification filed by Preventive Care, Inc. with the FDA for Savacare Latex Examination Gloves.
Device ID | K924233 |
510k Number | K924233 |
Device Name: | SAVACARE LATEX EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | PREVENTIVE CARE, INC. 2915 WATERS RD. #100 Eagan, MN 55121 |
Contact | Anil Segat |
Correspondent | Anil Segat PREVENTIVE CARE, INC. 2915 WATERS RD. #100 Eagan, MN 55121 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-24 |
Decision Date | 1993-03-12 |