The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Schultz Mp Component Punch.
Device ID | K870846 |
510k Number | K870846 |
Device Name: | SCHULTZ MP COMPONENT PUNCH |
Classification | Punch, Femoral Neck |
Applicant | WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
Contact | James Ritter |
Correspondent | James Ritter WARSAW ORTHOPEDIC, INC. P.O. BOX 1157 Warsaw, IN 46580 |
Product Code | HWP |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1987-03-13 |