The following data is part of a premarket notification filed by Infection Control Products, Inc. with the FDA for 4/1 Armboard.
| Device ID | K900175 |
| 510k Number | K900175 |
| Device Name: | 4/1 ARMBOARD |
| Classification | Board, Arm (with Cover), Sterile |
| Applicant | INFECTION CONTROL PRODUCTS, INC. P.O. DRAWER 739 1019 GRUBBS AVENUE Gardendale, AL 35071 |
| Contact | Patrick Russell |
| Correspondent | Patrick Russell INFECTION CONTROL PRODUCTS, INC. P.O. DRAWER 739 1019 GRUBBS AVENUE Gardendale, AL 35071 |
| Product Code | BTX |
| CFR Regulation Number | 878.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-12 |
| Decision Date | 1990-01-24 |