The following data is part of a premarket notification filed by Jack Speer And Assoc., Inc. with the FDA for Jsa's Reprocessed Compression Sleeve Devices.
| Device ID | K040065 |
| 510k Number | K040065 |
| Device Name: | JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | JACK SPEER AND ASSOC., INC. 1800 EAST 900 SOUTH Salt Lake City, UT 84108 |
| Contact | Jack Speer |
| Correspondent | Jack Speer JACK SPEER AND ASSOC., INC. 1800 EAST 900 SOUTH Salt Lake City, UT 84108 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-13 |
| Decision Date | 2004-03-29 |
| Summary: | summary |