The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Modified Reflux Reducer.
| Device ID | K883818 |
| 510k Number | K883818 |
| Device Name: | MODIFIED REFLUX REDUCER |
| Classification | Bed, Pediatric Open Hospital |
| Applicant | PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
| Contact | Rose, Md |
| Correspondent | Rose, Md PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
| Product Code | FMS |
| CFR Regulation Number | 880.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-08 |
| Decision Date | 1988-11-21 |