The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Sharpsite Ac.
| Device ID | K965233 |
| 510k Number | K965233 |
| Device Name: | SHARPSITE AC |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | David Timlin |
| Correspondent | David Timlin XOMED, INC. 6743 SOUTHPOINT DR. 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 | 1996-12-31 |
| Decision Date | 1997-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994672285 | K965233 | 000 |
| 00643169937444 | K965233 | 000 |
| 00643169937437 | K965233 | 000 |
| 00643169937420 | K965233 | 000 |
| 00681490047036 | K965233 | 000 |
| 00681490046992 | K965233 | 000 |
| 00681490046985 | K965233 | 000 |
| 00681490046947 | K965233 | 000 |
| 00681490046893 | K965233 | 000 |
| 00643169937451 | K965233 | 000 |
| 00643169937468 | K965233 | 000 |
| 00613994672278 | K965233 | 000 |
| 00613994128270 | K965233 | 000 |
| 00613994128263 | K965233 | 000 |
| 00613994128256 | K965233 | 000 |
| 00613994128249 | K965233 | 000 |
| 00613994128232 | K965233 | 000 |
| 00613994128225 | K965233 | 000 |
| 00643169937475 | K965233 | 000 |
| 00681490046855 | K965233 | 000 |