| Device Type ID | 4958 | 
| Device Name | Bath, Flotation, Tissue | 
| Regulation Description | Tissue Processing Equipment. | 
| Regulation Medical Specialty | Pathology | 
| Review Panel | Pathology | 
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health  (OIR) | 
| Submission Type | 510(K) Exempt | 
| CFR Regulation Number | 864.3010 [🔎] | 
| FDA Device Classification | Class 1 Medical Device | 
| Product Code | IDY | 
| GMP Exempt | Yes | 
| Summary MR | Eligible | 
| Implanted Device | No | 
| Life Support Device | No | 
| Third Party Review | Not Third Party Eligible | 
| Device Type ID | 4958 | 
| Device | Bath, Flotation, Tissue | 
| Product Code | IDY | 
| FDA Device Classification | Class 1 Medical Device | 
| Regulation Description | Tissue Processing Equipment. | 
| CFR Regulation Number | 864.3010 [🔎] |