The following data is part of a premarket notification filed by Sam Medical Products with the FDA for Chito-sam 100,4in X4in,chito-sam, 3in X6ft, Chito-sam 100,3in X10ft, Chito-sam Active, 4inx4in,chito-sam Active, 3inx6ft.
| Device ID | K133121 |
| 510k Number | K133121 |
| Device Name: | CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT |
| Classification | Dressing, Wound, Drug |
| Applicant | SAM MEDICAL PRODUCTS 27350 SW 95TH AVE STE 3038 Wilsonville, OR 97070 |
| Contact | Jack Mccutcheon |
| Correspondent | Jack Mccutcheon SAM MEDICAL PRODUCTS 27350 SW 95TH AVE STE 3038 Wilsonville, OR 97070 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822045000336 | K133121 | 000 |
| 10822045000022 | K133121 | 000 |
| 10822045000008 | K133121 | 000 |