The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Euro-med Endo-curette.
Device ID | K882606 |
510k Number | K882606 |
Device Name: | EURO-MED ENDO-CURETTE |
Classification | Sampler, Endocervical |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | PCF |
CFR Regulation Number | 884.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-24 |
Decision Date | 1988-07-25 |