The following data is part of a premarket notification filed by Inmed Corp. with the FDA for Brooks Sclerotherapy Cuff.
| Device ID | K823475 |
| 510k Number | K823475 |
| Device Name: | BROOKS SCLEROTHERAPY CUFF |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Contact | Flo Becker |
| Correspondent | Flo Becker INMED CORP. 3030-B HOLCOMB BRIDGE RD. Norcross, GA 30071 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-22 |
| Decision Date | 1983-07-12 |