The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Landmark Venous Access Drive (additional Sizes).
Device ID | K883980 |
510k Number | K883980 |
Device Name: | LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES) |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto, CA 94303 |
Contact | Dwayne Hardy |
Correspondent | Dwayne Hardy MENLO CARE, INC. 1053 EAST MEADOW CIRCLE Palo Alto, CA 94303 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-21 |
Decision Date | 1988-12-05 |