Submission Details
| 510(k) Number | K883214 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 1988 |
| Decision Date | January 17, 1989 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
Cleared
Traditional
THORACIC SUPPORT SYSTEM
Jan 1989
Decision
172d
Days
Class 1
Risk
About This 510(k) Submission
K883214 is an FDA 510(k) clearance for the THORACIC SUPPORT SYSTEM, a Binder, Elastic (Class I — General Controls, product code KMO), submitted by Storer Medical Products (Del Mar, US). The FDA issued a Cleared decision on January 17, 1989, 172 days after receiving the submission on July 29, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5160.
Device Classification
| Product Code | KMO — Binder, Elastic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5160 |
Manufacturer
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