The following data is part of a premarket notification filed by Hospital For Special Surgery with the FDA for Plamp, Plamp Plate, Plamp With Hook.
Device ID | K942032 |
510k Number | K942032 |
Device Name: | PLAMP, PLAMP PLATE, PLAMP WITH HOOK |
Classification | Plate, Fixation, Bone |
Applicant | HOSPITAL FOR SPECIAL SURGERY 535 EAST 70TH ST. New York, NY 10021 |
Contact | Bruce H Robie |
Correspondent | Bruce H Robie HOSPITAL FOR SPECIAL SURGERY 535 EAST 70TH ST. New York, NY 10021 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-26 |
Decision Date | 1996-06-13 |
Summary: | summary |