510(k) K792629
- Device
- STERILIZATION PROCESS/T-BINDER
- Applicant
- PROCTER & GAMBLE MFG. CO.
- 510(k) number
- K792629
- Product code
- KMO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-11
- Date received
- 1979-12-19
- Regulation
- 880.5160
- Classification name
- Binder, Elastic
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3012429608
- 3007123908
- 8043954
- 3008381107
- 3014407894
- 3006943846
- 1646747
- 3022298582
- 9710641
- 9616914
- 3003902312
- 3005550595
- 1417592
- 3006755899
- 1450371
- 1836161
- 9616933
- 3003905499
- 1221770
- 3014144875
- 1000641183
- 1062254
- 3007740574
- 3008008970
- 3008863514
- 2131610
- 3008970204
- 3005855077
- 8030607
- 2025918
- 1063312
- 3009273990
- 9617759
- 3007076137
- 3004511024
- 2027804
- 3008114969
- 3005273623
- 1057079
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KMO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921852 | 4 SURE TM RECTAL TUBE | Boston Pacific Medical, Inc. | 1993-10-08 |
| K893809 | COUGH PILLOW | Custom Hospitals Products | 1989-08-28 |
| K883214 | THORACIC SUPPORT SYSTEM | Storer Medical Products | 1989-01-17 |
| K882592 | HEART HUGGER STERNUM SUPPORT HARNESS | General Cardiac Technology, Inc. | 1988-09-20 |
Legacy Summary#
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FDA Review#
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