The following data is part of a premarket notification filed by Morning Star, Dong Bang Acupuncture U.s.a., Inc. with the FDA for Dbc, Dong Bang Acupuncture Needles.
Device ID | K990328 |
510k Number | K990328 |
Device Name: | DBC, DONG BANG ACUPUNCTURE NEEDLES |
Classification | Needle, Acupuncture, Single Use |
Applicant | MORNING STAR, DONG BANG ACUPUNCTURE U.S.A., INC. 1429 LYNDON ST. South Pasadena, CA 91030 |
Contact | Ae-hoe Kwon |
Correspondent | Ae-hoe Kwon MORNING STAR, DONG BANG ACUPUNCTURE U.S.A., INC. 1429 LYNDON ST. South Pasadena, CA 91030 |
Product Code | MQX |
CFR Regulation Number | 880.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-02 |
Decision Date | 1999-05-04 |
Summary: | summary |