The following data is part of a premarket notification filed by R-med, Inc. with the FDA for R-med Disposable Plug.
| Device ID | K942411 |
| 510k Number | K942411 |
| Device Name: | R-MED DISPOSABLE PLUG |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | R-MED, INC. 3465 NAVARRE AVE. BOX 167636 Oregon, OH 43616 -7636 |
| Contact | Erol D Riza |
| Correspondent | Erol D Riza R-MED, INC. 3465 NAVARRE AVE. BOX 167636 Oregon, OH 43616 -7636 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1995-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B44510154 | K942411 | 000 |
| B44510152 | K942411 | 000 |