The following data is part of a premarket notification filed by Hemaway Llc with the FDA for Hemaway Seat.
| Device ID | K072690 |
| 510k Number | K072690 |
| Device Name: | HEMAWAY SEAT |
| Classification | Cushion, Hemorrhoid |
| Applicant | HEMAWAY LLC 2207 CONCORD PIKE, SUITE 528 Wilmington, DE 19803 |
| Contact | Archie Rosenblum |
| Correspondent | Archie Rosenblum HEMAWAY LLC 2207 CONCORD PIKE, SUITE 528 Wilmington, DE 19803 |
| Product Code | LRL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-24 |
| Decision Date | 2007-12-07 |
| Summary: | summary |