The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Correct Flo.
| Device ID | K851299 |
| 510k Number | K851299 |
| Device Name: | CORRECT FLO |
| Classification | Set, Administration, Intravascular |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. P.O. BOX 3660 Akron, OH 44309 |
| Contact | Roger Mogill |
| Correspondent | Roger Mogill NORTON PERFORMANCE PLASTICS CORP. P.O. BOX 3660 Akron, OH 44309 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-05-07 |