The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Endoscope Sheath.
| Device ID | K940028 |
| 510k Number | K940028 |
| Device Name: | ENDOSCOPE SHEATH |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Contact | Arthur A Gertzman |
| Correspondent | Arthur A Gertzman XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville, FL 32216 -0980 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1995-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074060316 | K940028 | 000 |