The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Polyethylene Medullary Plug - Stiihmer/.
| Device ID | K830949 |
| 510k Number | K830949 |
| Device Name: | POLYETHYLENE MEDULLARY PLUG - STIIHMER/ |
| Classification | Cement Obturator |
| Applicant | ALLO PRO CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-24 |
| Decision Date | 1983-04-12 |