The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Kangaroo Feeding Tube Placment Stylet.
Device ID | K960632 |
510k Number | K960632 |
Device Name: | KANGAROO FEEDING TUBE PLACMENT STYLET |
Classification | Tubes, Gastrointestinal (and Accessories) |
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 | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-14 |
Decision Date | 1996-05-09 |
Summary: | summary |