The following data is part of a premarket notification filed by Patrick J. O'regan with the FDA for O'regan Ligator.
Device ID | K963166 |
510k Number | K963166 |
Device Name: | O'REGAN LIGATOR |
Classification | Ligator, Hemorrhoidal |
Applicant | PATRICK J. O'REGAN 912 - 750 WEST BROADWAY Vancouver, CA V5z 1h8 |
Contact | Patrick J O'regan |
Correspondent | Patrick J O'regan PATRICK J. O'REGAN 912 - 750 WEST BROADWAY Vancouver, CA V5z 1h8 |
Product Code | FHN |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-14 |
Decision Date | 1997-05-05 |
Summary: | summary |