The following data is part of a premarket notification filed by Berwick Medical Products, Inc. with the FDA for Dropstirs - Plastic Disposable Pipet.
Device ID | K850800 |
510k Number | K850800 |
Device Name: | DROPSTIRS - PLASTIC DISPOSABLE PIPET |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | BERWICK MEDICAL PRODUCTS, INC. P.O. BOX 2548 Warminster, PA 18974 |
Contact | Susan M Stouffer |
Correspondent | Susan M Stouffer BERWICK MEDICAL PRODUCTS, INC. P.O. BOX 2548 Warminster, PA 18974 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-27 |
Decision Date | 1985-04-02 |