The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Wire Tension Clamp.
| Device ID | K901984 |
| 510k Number | K901984 |
| Device Name: | ACE WIRE TENSION CLAMP |
| Classification | Component, Traction, Invasive |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-02 |
| Decision Date | 1990-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868001581 | K901984 | 000 |
| 00887868001574 | K901984 | 000 |
| 00887868001543 | K901984 | 000 |
| 00887868001536 | K901984 | 000 |
| 00887868047701 | K901984 | 000 |