The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Kartush Tm Patcher.
| Device ID | K964484 |
| 510k Number | K964484 |
| Device Name: | KARTUSH TM PATCHER |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| 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 | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-07 |
| Decision Date | 1997-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490040518 | K964484 | 000 |
| 00681490040501 | K964484 | 000 |
| 00681490040495 | K964484 | 000 |
| 00681490040488 | K964484 | 000 |
| 00763000035624 | K964484 | 000 |
| 00763000035617 | K964484 | 000 |
| 00763000035600 | K964484 | 000 |
| 00763000035594 | K964484 | 000 |