The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Plug-lok Cement Restirctor.
| Device ID | K791125 |
| 510k Number | K791125 |
| Device Name: | PLUG-LOK CEMENT RESTIRCTOR |
| Classification | Cement Obturator |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-18 |
| Decision Date | 1979-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23596010493624 | K791125 | 000 |
| 03596010061140 | K791125 | 000 |
| 23596010086437 | K791125 | 000 |
| 23596010086444 | K791125 | 000 |
| 23596010191070 | K791125 | 000 |
| 23596010191087 | K791125 | 000 |
| 23596010416807 | K791125 | 000 |
| 03596010473448 | K791125 | 000 |
| 03596010473455 | K791125 | 000 |
| 03596010473479 | K791125 | 000 |
| 03596010485694 | K791125 | 000 |
| 03596010485700 | K791125 | 000 |
| 03596010485717 | K791125 | 000 |
| 23596010493600 | K791125 | 000 |
| 23596010493617 | K791125 | 000 |
| 23596010457121 | K791125 | 000 |