The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Arterial Catheter.
Device ID | K851327 |
510k Number | K851327 |
Device Name: | DESERET ARTERIAL CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
Contact | Edward F Cleary |
Correspondent | Edward F Cleary PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-04 |
Decision Date | 1985-06-14 |