The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Model 6325 Scd Sequel Compression System.
| Device ID | K942664 |
| 510k Number | K942664 |
| Device Name: | KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Contact | Dean E Ciporkin |
| Correspondent | Dean E Ciporkin THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1995-01-17 |