The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Bend-a-beam Hand Control Malleable Abc Handpiece.
| Device ID | K961505 |
| 510k Number | K961505 |
| Device Name: | BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Contact | Ira D Duesler, Jr. |
| Correspondent | Ira D Duesler, Jr. CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-19 |
| Decision Date | 1996-07-18 |