The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Polyurethane Salem Sump Tube.
Device ID | K910479 |
510k Number | K910479 |
Device Name: | ARGYLE POLYURETHANE SALEM SUMP TUBE |
Classification | Tube, Nasogastric |
Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
Contact | Dennis Pozzo |
Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MS 63103 |
Product Code | BSS |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-06 |
Decision Date | 1991-04-19 |