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 |