The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Laparoscopic Suction Probe.
Device ID | K893527 |
510k Number | K893527 |
Device Name: | LAPAROSCOPIC SUCTION PROBE |
Classification | Catheter And Tip, Suction |
Applicant | DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
Contact | Mary K Bruch |
Correspondent | Mary K Bruch DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-08 |
Decision Date | 1989-07-14 |