The following data is part of a premarket notification filed by Sam Medical Products with the FDA for Sam Chest Seal With Vavle; Sam Chest Seal.
| Device ID | K102403 |
| 510k Number | K102403 |
| Device Name: | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL |
| Classification | Dressing, Wound, Occlusive |
| Applicant | SAM MEDICAL PRODUCTS 27350 SW 95th Ave Ste 3038 Bldg 30 Wilsonville, OR 97070 |
| Contact | Jack N Mccutcheon |
| Correspondent | Jack N Mccutcheon SAM MEDICAL PRODUCTS 27350 SW 95th Ave Ste 3038 Bldg 30 Wilsonville, OR 97070 |
| Product Code | NAD |
| CFR Regulation Number | 878.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-24 |
| Decision Date | 2011-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822045000190 | K102403 | 000 |
| 10822045000183 | K102403 | 000 |
| 20822045000173 | K102403 | 000 |