The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Intermittent Injection Site.
Device ID | K923323 |
510k Number | K923323 |
Device Name: | INTERMITTENT INJECTION SITE |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
Contact | Shozo Moriyama |
Correspondent | Shozo Moriyama KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-07 |
Decision Date | 1993-07-13 |