The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Kangaroo(r) Pet(tm) Enteral Feed Pump/charger Base.
Device ID | K913413 |
510k Number | K913413 |
Device Name: | KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE |
Classification | Pump, Infusion, Enteral |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | Dennis Pozzo |
Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-31 |
Decision Date | 1991-11-29 |