The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Change In Sterilization Procedure.
| Device ID | K781727 |
| 510k Number | K781727 |
| Device Name: | CHANGE IN STERILIZATION PROCEDURE |
| Classification | Antisera, Agglutinating, B. Pertussis, All |
| Applicant | ABSORBENT COTTON CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GOY |
| CFR Regulation Number | 866.3065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-11 |
| Decision Date | 1978-12-04 |