The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Manual Percussor Cups.
Device ID | K883899 |
510k Number | K883899 |
Device Name: | MANUAL PERCUSSOR CUPS |
Classification | Percussor, Powered-electric |
Applicant | MEDICAL COMPONENTS, INC. 411 FREMONT ST. Anoka, MN 55303 |
Contact | Duncan G Johnson |
Correspondent | Duncan G Johnson MEDICAL COMPONENTS, INC. 411 FREMONT ST. Anoka, MN 55303 |
Product Code | BYI |
CFR Regulation Number | 868.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-15 |
Decision Date | 1988-12-13 |