The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Heating Block, Wampole 37 C.
| Device ID | K790549 |
| 510k Number | K790549 |
| Device Name: | HEATING BLOCK, WAMPOLE 37 C |
| Classification | Block, Heating |
| Applicant | ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JRG |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-20 |
| Decision Date | 1979-05-03 |