The following data is part of a premarket notification filed by Storer Medical Products with the FDA for Thoracic Support System.
Device ID | K883214 |
510k Number | K883214 |
Device Name: | THORACIC SUPPORT SYSTEM |
Classification | Binder, Elastic |
Applicant | STORER MEDICAL PRODUCTS 2148 JIMMY DURANTE BLVD. #F Del Mar, CA 92014 |
Contact | Darwin L Storer |
Correspondent | Darwin L Storer STORER MEDICAL PRODUCTS 2148 JIMMY DURANTE BLVD. #F Del Mar, CA 92014 |
Product Code | KMO |
CFR Regulation Number | 880.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-29 |
Decision Date | 1989-01-17 |