The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Modified Model 5320 T.e.d. Compression Limb.
| Device ID | K863581 |
| 510k Number | K863581 |
| Device Name: | MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB |
| Classification | Sleeve, Limb, Compressible |
| Applicant | THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Contact | Mark W Wenzel |
| Correspondent | Mark W Wenzel THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-15 |
| Decision Date | 1986-10-31 |