The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for Medcare Suction Connecting Tubing.
Device ID | K961880 |
510k Number | K961880 |
Device Name: | MEDCARE SUCTION CONNECTING TUBING |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
Contact | Craig J Bell |
Correspondent | Craig J Bell MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-15 |
Decision Date | 1996-07-19 |
Summary: | summary |