The following data is part of a premarket notification filed by Helps Products, Inc. with the FDA for Natelson Tubes, Heparin And Plain.
| Device ID | K881187 |
| 510k Number | K881187 |
| Device Name: | NATELSON TUBES, HEPARIN AND PLAIN |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | HELPS PRODUCTS, INC. 4469 S.W.35TH.STREET Orlando, FL 32811 |
| Contact | Brian Lemay |
| Correspondent | Brian Lemay HELPS PRODUCTS, INC. 4469 S.W.35TH.STREET Orlando, FL 32811 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-05-06 |