The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Endo-scrub/endo-scrub 2.
| Device ID | K982594 |
| 510k Number | K982594 |
| Device Name: | ENDO-SCRUB/ENDO-SCRUB 2 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Debra B Cortner |
| Correspondent | Debra B Cortner 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 | 1998-07-24 |
| Decision Date | 1998-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169437276 | K982594 | 000 |
| 20681490050986 | K982594 | 000 |
| 20681490050962 | K982594 | 000 |
| 20681490050948 | K982594 | 000 |
| 20681490050924 | K982594 | 000 |
| 20681490050917 | K982594 | 000 |
| 20681490050900 | K982594 | 000 |
| 20681490050894 | K982594 | 000 |
| 20681490050887 | K982594 | 000 |
| 20681490050870 | K982594 | 000 |
| 20681490050863 | K982594 | 000 |
| 20681490050856 | K982594 | 000 |
| 20681490050993 | K982594 | 000 |
| 20681490465414 | K982594 | 000 |
| 20681490465421 | K982594 | 000 |
| 20643169437269 | K982594 | 000 |
| 20643169437252 | K982594 | 000 |
| 20643169437245 | K982594 | 000 |
| 20643169437238 | K982594 | 000 |
| 20643169437221 | K982594 | 000 |
| 20643169437214 | K982594 | 000 |
| 20643169437207 | K982594 | 000 |
| 00643169360884 | K982594 | 000 |
| 20681490697785 | K982594 | 000 |
| 20681490697761 | K982594 | 000 |
| 20681490697754 | K982594 | 000 |
| 20681490050849 | K982594 | 000 |