The following data is part of a premarket notification filed by Fls Medical Products, Inc. with the FDA for Fls Med. Prod. Racine Type Adaptor.
| Device ID | K853828 |
| 510k Number | K853828 |
| Device Name: | FLS MED. PROD. RACINE TYPE ADAPTOR |
| Classification | Connector, Airway (extension) |
| Applicant | FLS MEDICAL PRODUCTS, INC. 5081 69TH. AVENUE NORTH Pinellas Park, FL 33565 |
| Contact | Francis L Sandel |
| Correspondent | Francis L Sandel FLS MEDICAL PRODUCTS, INC. 5081 69TH. AVENUE NORTH Pinellas Park, FL 33565 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-13 |
| Decision Date | 1985-10-29 |