The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Modified Disp. Chiba-type Needle Designated Aspi..
Device ID | K896019 |
510k Number | K896019 |
Device Name: | MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Contact | Chet Vanhof |
Correspondent | Chet Vanhof DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Product Code | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-16 |
Decision Date | 1990-01-03 |