The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Heparinized Saratoga Sump Drain.
Device ID | K760813 |
510k Number | K760813 |
Device Name: | HEPARINIZED SARATOGA SUMP DRAIN |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-12 |
Decision Date | 1976-11-03 |