The following data is part of a premarket notification filed by Opap, Inc. with the FDA for Opap.
Device ID | K991926 |
510k Number | K991926 |
Device Name: | OPAP |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | OPAP, INC. 26037 SUGAR PINE DR. Pioneer, CA 95666 -0189 |
Contact | William T Hart |
Correspondent | William T Hart OPAP, INC. 26037 SUGAR PINE DR. Pioneer, CA 95666 -0189 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-07 |
Decision Date | 1999-10-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPAP 98462650 not registered Live/Pending |
Balance Ophthalmics, Inc. 2024-03-22 |
OPAP 87109618 5146679 Live/Registered |
Shenzhen Weidun Technology Co.,Ltd 2016-07-20 |
OPAP 75127746 2131260 Live/Registered |
OPAP, INC 1996-07-01 |