The following data is part of a premarket notification filed by G & H Wire Co. with the FDA for Safety Release Module.
| Device ID | K961754 |
| 510k Number | K961754 |
| Device Name: | SAFETY RELEASE MODULE |
| Classification | Headgear, Extraoral, Orthodontic |
| Applicant | G & H WIRE CO. 1791 INDUSTRIAL DR. Greenwood, IN 46142 |
| Contact | Michael Jahns |
| Correspondent | Michael Jahns G & H WIRE CO. 1791 INDUSTRIAL DR. Greenwood, IN 46142 |
| Product Code | DZB |
| CFR Regulation Number | 872.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-06 |
| Decision Date | 1996-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040018651 | K961754 | 000 |
| 10843471148140 | K961754 | 000 |
| 10840326406332 | K961754 | 000 |
| 10840326406356 | K961754 | 000 |
| 10840326406349 | K961754 | 000 |
| 00842452100651 | K961754 | 000 |
| 00842452100668 | K961754 | 000 |
| 00842452100675 | K961754 | 000 |
| 00190707000356 | K961754 | 000 |
| 00190707000363 | K961754 | 000 |
| 00190707005542 | K961754 | 000 |
| 00190707005566 | K961754 | 000 |
| 00190707005573 | K961754 | 000 |
| 00304040018644 | K961754 | 000 |
| 10840326406325 | K961754 | 000 |