The following data is part of a premarket notification filed by J. T. Posey Co. with the FDA for Posey Hugger.
Device ID | K963409 |
510k Number | K963409 |
Device Name: | POSEY HUGGER |
Classification | Restraint, Protective |
Applicant | J. T. POSEY CO. 5635 PECK RD. Arcadia, CA 91006 |
Contact | Michael Keefe |
Correspondent | Michael Keefe J. T. POSEY CO. 5635 PECK RD. Arcadia, CA 91006 |
Product Code | FMQ |
CFR Regulation Number | 880.6760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-30 |
Decision Date | 1996-11-14 |
Summary: | summary |