The following data is part of a premarket notification filed by Robert I. Chien & Assoc., Inc. with the FDA for Unsterilized Laparotomy Sponges (china).
Device ID | K811632 |
510k Number | K811632 |
Device Name: | UNSTERILIZED LAPAROTOMY SPONGES (CHINA) |
Classification | Gauze/sponge, Internal, X-ray Detectable |
Applicant | ROBERT I. CHIEN & ASSOC., INC. 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 | 1981-06-09 |
Decision Date | 1981-09-11 |