The following data is part of a premarket notification filed by R D Intl. with the FDA for Suction Safety Device.
Device ID | K960937 |
510k Number | K960937 |
Device Name: | SUCTION SAFETY DEVICE |
Classification | Cpb Check Valve, Retrograde Flow, In-line |
Applicant | R D INTL. 304 ARBORCREST Richardson, TX 75080 |
Contact | Mike Davis |
Correspondent | Mike Davis R D INTL. 304 ARBORCREST Richardson, TX 75080 |
Product Code | MJJ |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-08 |
Decision Date | 1996-06-05 |
Summary: | summary |