The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Medcare Yankauer Suction Device.
| Device ID | K954869 |
| 510k Number | K954869 |
| Device Name: | MEDCARE YANKAUER SUCTION DEVICE |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. 234 OLD HOMESTEAD HIGHWAY ROUTE 32 East Swanzey, NH 03446 |
| Contact | Craig J Bell |
| Correspondent | Craig J Bell MEDCARE CUSTOM PACKAGING, INC. 234 OLD HOMESTEAD HIGHWAY ROUTE 32 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 | 1995-10-24 |
| Decision Date | 1996-01-19 |