The following data is part of a premarket notification filed by American Fluoroseal Corp. with the FDA for Tissue Culture Bag.
| Device ID | K870865 |
| 510k Number | K870865 |
| Device Name: | TISSUE CULTURE BAG |
| Classification | Flask, Tissue Culture |
| Applicant | AMERICAN FLUOROSEAL CORP. 204 STONEGATE DR. Silver Spring, MD 20904 |
| Contact | Charles Soodak |
| Correspondent | Charles Soodak AMERICAN FLUOROSEAL CORP. 204 STONEGATE DR. Silver Spring, MD 20904 |
| Product Code | KJA |
| CFR Regulation Number | 864.2240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-03-30 |