The following data is part of a premarket notification filed by William Harvey Life Products Corp. with the FDA for Scott Cm42 Pasteurizer.
Device ID | K810065 |
510k Number | K810065 |
Device Name: | SCOTT CM42 PASTEURIZER |
Classification | Pump, Breast, Powered |
Applicant | WILLIAM HARVEY LIFE PRODUCTS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-13 |
Decision Date | 1981-01-28 |