The following data is part of a premarket notification filed by Porta-stat, Inc. with the FDA for Porta-stat.
| Device ID | K843340 |
| 510k Number | K843340 |
| Device Name: | PORTA-STAT |
| Classification | Holder, Head, Radiographic |
| Applicant | PORTA-STAT, INC. 35129 DODGE PARK RD. Sterling Heights, MI 48077 |
| Contact | John L Spolyar |
| Correspondent | John L Spolyar PORTA-STAT, INC. 35129 DODGE PARK RD. Sterling Heights, MI 48077 |
| Product Code | IWY |
| CFR Regulation Number | 892.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-27 |
| Decision Date | 1984-11-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PORTA-STAT 73585554 1412197 Dead/Cancelled |
SPOLYAR, JOHN L. 1986-03-03 |