The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Ampri.
Device ID | K954002 |
510k Number | K954002 |
Device Name: | AMPRI |
Classification | Surgeon's Gloves |
Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT 10, UNIT TYPE A, KAWASAN MIEL PHASE II 4300 BATANG KALI Selangor, MY |
Contact | May Phng |
Correspondent | May Phng AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT 10, UNIT TYPE A, KAWASAN MIEL PHASE II 4300 BATANG KALI Selangor, MY |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-25 |
Decision Date | 1996-01-29 |