The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Dispos-a-care Thermometer Sheath.
Device ID | K770125 |
510k Number | K770125 |
Device Name: | DISPOS-A-CARE THERMOMETER SHEATH |
Classification | Thermometer, Clinical Mercury |
Applicant | CHESEBROUGH-POND'S U.S.A. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-01-21 |
Decision Date | 1977-03-14 |