The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Ampri.
Device ID | K952833 |
510k Number | K952833 |
Device Name: | AMPRI |
Classification | Latex Patient Examination Glove |
Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD UNIT TYPE A, LOT 10 KAWASAN MIKEL, BATANG KALI, Phase Ii 44300 Batang Kali, MY |
Contact | Mike Scolari |
Correspondent | Mike Scolari AMPRI RUBBERWARE INDUSTRIES SDN BHD UNIT TYPE A, LOT 10 KAWASAN MIKEL, BATANG KALI, Phase Ii 44300 Batang Kali, MY |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-20 |
Decision Date | 1995-09-05 |