4 SURE TM RECTAL TUBE
FDA 510(k) clearance K921852 · decided 1993-10-08
Clearance details
- K-number
- K921852
- Device name
- 4 SURE TM RECTAL TUBE
- Applicant
- Boston Pacific Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-17
- Decision date
- 1993-10-08
- Days to decision
- 539 days
- Clearance type
- Traditional
- Product code
- KMO
- Device class
- 1
- Regulation number
- 880.5160
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COUGH PILLOW (K893809) | Custom Hospitals Products | 1989-08-28 |
| THORACIC SUPPORT SYSTEM (K883214) | Storer Medical Products | 1989-01-17 |
| HEART HUGGER STERNUM SUPPORT HARNESS (K882592) | General Cardiac Technology, Inc. | 1988-09-20 |
| STERILIZATION PROCESS/T-BINDER (K792629) | Procter & Gamble Mfg. Co. | 1980-01-11 |
Recalls involving this device
No recalls on record reference this clearance.