The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Cholangiograph Balloon Catheter By J-lloyd Medical, Inc..
Device ID | K974336 |
510k Number | K974336 |
Device Name: | CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
Contact | James L Skaggs |
Correspondent | James L Skaggs J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-18 |
Decision Date | 1998-02-13 |
Summary: | summary |