The following data is part of a premarket notification filed by Gi Supply with the FDA for Oxy-bloc.
Device ID | K931044 |
510k Number | K931044 |
Device Name: | OXY-BLOC |
Classification | Endoscopic Bite Block |
Applicant | GI SUPPLY 423N. 21ST ST. Camp Hill, PA 17011 |
Contact | Frank W Jackson |
Correspondent | Frank W Jackson GI SUPPLY 423N. 21ST ST. Camp Hill, PA 17011 |
Product Code | MNK |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-01 |
Decision Date | 1993-10-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10893029002523 | K931044 | 000 |
10893029002561 | K931044 | 000 |
10893029002554 | K931044 | 000 |
10893029002547 | K931044 | 000 |
10893029002530 | K931044 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OXY-BLOC 78532861 3269264 Dead/Cancelled |
AKZO NOBEL COATINGS INC. 2004-12-15 |