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 |