The following data is part of a premarket notification filed by Laparomed Corp. with the FDA for Laparomed Cholangiogram Vacuum Device.
| Device ID | K910218 |
| 510k Number | K910218 |
| Device Name: | LAPAROMED CHOLANGIOGRAM VACUUM DEVICE |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Contact | Paul Lubock |
| Correspondent | Paul Lubock LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-17 |
| Decision Date | 1991-04-08 |