The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Patient Positioning Accessories.
Device ID | K895500 |
510k Number | K895500 |
Device Name: | PATIENT POSITIONING ACCESSORIES |
Classification | Accelerator, Linear, Medical |
Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Contact | James C Furse |
Correspondent | James C Furse PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-12 |
Decision Date | 1989-11-06 |