The following data is part of a premarket notification filed by Engineered Orthopedic Technologies, Inc. with the FDA for Malcolm-lynn(tm) Eot Suction Reg Valve(tm) (srv) ).
| Device ID | K942747 |
| 510k Number | K942747 |
| Device Name: | MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) |
| Classification | Regulator, Vacuum |
| Applicant | ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC. 920-C CALLE NEGOCIO San Clemente, CA 92672 -6207 |
| Contact | James Barley |
| Correspondent | James Barley ENGINEERED ORTHOPEDIC TECHNOLOGIES, INC. 920-C CALLE NEGOCIO San Clemente, CA 92672 -6207 |
| Product Code | KDP |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1994-07-21 |