The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact Turbo Cath.
Device ID | K851611 |
510k Number | K851611 |
Device Name: | IMPACT TURBO CATH |
Classification | Catheter And Tip, Suction |
Applicant | IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota, NJ 07603 |
Contact | Leslie H Sherman |
Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota, NJ 07603 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-09 |
Decision Date | 1985-06-05 |