The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Non-weighted Polyurethane Enteral Feeding Tube.
Device ID | K914375 |
510k Number | K914375 |
Device Name: | NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | Dennis Pozza |
Correspondent | Dennis Pozza 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 | 1991-10-01 |
Decision Date | 1992-03-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521143944 | K914375 | 000 |
10884521143937 | K914375 | 000 |
10884521143913 | K914375 | 000 |
10884521143890 | K914375 | 000 |
10884521033627 | K914375 | 000 |
10884521033610 | K914375 | 000 |
20884521033600 | K914375 | 000 |