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 |