The following data is part of a premarket notification filed by Lukens Corp. with the FDA for Stanford Sterile Lap Sponges.
Device ID | K800102 |
510k Number | K800102 |
Device Name: | STANFORD STERILE LAP SPONGES |
Classification | Gauze/sponge, Internal, X-ray Detectable |
Applicant | LUKENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GDY |
CFR Regulation Number | 878.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-16 |
Decision Date | 1980-01-28 |