The following data is part of a premarket notification filed by Fenwal Laboratories with the FDA for Tissue Culture Flask.
| Device ID | K864021 |
| 510k Number | K864021 |
| Device Name: | TISSUE CULTURE FLASK |
| Classification | Flask, Tissue Culture |
| Applicant | FENWAL LABORATORIES DIVISION OF TRAVENOL LABS Round Lake, IL 60073 |
| Contact | John Brda |
| Correspondent | John Brda FENWAL LABORATORIES DIVISION OF TRAVENOL LABS Round Lake, IL 60073 |
| Product Code | KJA |
| CFR Regulation Number | 864.2240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-15 |
| Decision Date | 1986-10-29 |