The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Nucleotome.
Device ID | K844131 |
510k Number | K844131 |
Device Name: | NUCLEOTOME |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Contact | William T George |
Correspondent | William T George MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Product Code | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-23 |
Decision Date | 1984-11-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B067235351 | K844131 | 000 |
B067235001 | K844131 | 000 |
B067225001 | K844131 | 000 |
B067110000 | K844131 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NUCLEOTOME 73667083 1480701 Dead/Cancelled |
SURGICAL DYNAMICS, INC. 1987-06-18 |
NUCLEOTOME 73512585 1383244 Live/Registered |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 1984-12-07 |