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 |