The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for White Knight Drape Seal.
Device ID | K802280 |
510k Number | K802280 |
Device Name: | WHITE KNIGHT DRAPE SEAL |
Classification | Drape, Surgical |
Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-18 |
Decision Date | 1980-10-10 |