The following data is part of a premarket notification filed by Chi'am Intl. with the FDA for Peri-comfort(tm) Seating Cushion.
Device ID | K932396 |
510k Number | K932396 |
Device Name: | PERI-COMFORT(TM) SEATING CUSHION |
Classification | Cushion, Hemorrhoid |
Applicant | CHI'AM INTL. P.O. BOX 445 Circle Pines, MN 55014 |
Contact | Susan Wolf |
Correspondent | Susan Wolf CHI'AM INTL. P.O. BOX 445 Circle Pines, MN 55014 |
Product Code | LRL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-18 |
Decision Date | 1993-09-30 |