The following data is part of a premarket notification filed by Bio Medical Devices, Inc. with the FDA for Bio-prep.
Device ID | K931846 |
510k Number | K931846 |
Device Name: | BIO-PREP |
Classification | Orthopedic Manual Surgical Instrument |
Applicant | BIO MEDICAL DEVICES, INC. 1752 A LANGLEY AVE. Irvine, CA 92714 |
Contact | Nick Herbert |
Correspondent | Nick Herbert BIO MEDICAL DEVICES, INC. 1752 A LANGLEY AVE. Irvine, CA 92714 |
Product Code | LXH |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-13 |
Decision Date | 1994-01-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIO-PREP 73399690 1269673 Dead/Cancelled |
Ionics, Incorporated 1982-10-07 |