STERILIZATION PROCESS/T-BINDER
FDA 510(k) clearance K792629 · decided 1980-01-11
Clearance details
- K-number
- K792629
- Device name
- STERILIZATION PROCESS/T-BINDER
- Applicant
- Procter & Gamble Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-19
- Decision date
- 1980-01-11
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- KMO
- Device class
- 1
- Regulation number
- 880.5160
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Procter & Gamble Mfg. Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 4 SURE TM RECTAL TUBE (K921852) | Boston Pacific Medical, Inc. | 1993-10-08 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.