The following data is part of a premarket notification filed by Currie Medical Specialties, Inc. with the FDA for Currie Medical Alp Pediatric Calf Compression Sleeves (all Sizes).
| Device ID | K143317 |
| 510k Number | K143317 |
| Device Name: | Currie Medical ALP Pediatric Calf Compression Sleeves (all Sizes) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Currie Medical Specialties, Inc. 8758 Hellman Ave Rancho Cucamonga, CA 91730 |
| Contact | Owen J. Bry |
| Correspondent | Owen J. Bry Currie Medical Specialties, Inc. 8758 Hellman Ave Rancho Cucamonga, CA 91730 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-19 |
| Decision Date | 2015-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857910006581 | K143317 | 000 |
| 00857910006079 | K143317 | 000 |