The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Perfourm.
Device ID | K842324 |
510k Number | K842324 |
Device Name: | PERFOURM |
Classification | Material, Impression |
Applicant | CUTTER LABORATORIES, INC. P.O. BOX 1986 Berkeley , CA 94701 - |
Contact | Steven Ojala |
Correspondent | Steven Ojala CUTTER LABORATORIES, INC. P.O. BOX 1986 Berkeley , CA 94701 - |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-13 |
Decision Date | 1984-11-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PERFOURM 73669630 1476519 Dead/Cancelled |
MILES LABORATORIES, INC. 1987-07-01 |