The following data is part of a premarket notification filed by Hughes Int'l, Inc. with the FDA for Securipin.
Device ID | K844457 |
510k Number | K844457 |
Device Name: | SECURIPIN |
Classification | Pin, Retentive And Splinting, And Accessory Instruments |
Applicant | HUGHES INT'L, INC. 336 CLUBHOUSE RD. Hunt Valley, MD 21031 |
Contact | Susan Coburn |
Correspondent | Susan Coburn HUGHES INT'L, INC. 336 CLUBHOUSE RD. Hunt Valley, MD 21031 |
Product Code | EBL |
CFR Regulation Number | 872.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-16 |
Decision Date | 1984-12-27 |