The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Axiom Lig-a-boots.
| Device ID | K820161 |
| 510k Number | K820161 |
| Device Name: | AXIOM LIG-A-BOOTS |
| Classification | Instrument, Surgical, Disposable |
| Applicant | AXIOM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-20 |
| Decision Date | 1982-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6653003 | K820161 | 000 |
| M6656203 | K820161 | 000 |
| M6656103 | K820161 | 000 |
| M6656003 | K820161 | 000 |