510(k) K831207
- Device
- SPUNGUARD SCRUB SUIT
- Applicant
- KIMBERLY-CLARK CORP.
- 510(k) number
- K831207
- Product code
- FXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-16
- Date received
- 1983-04-12
- Regulation
- 878.4040
- Classification name
- Suit, Surgical
- Medical specialty
- General & Plastic Surgery
- 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#
- 9680887
- 3002957587
- 3016733390
- 3002637602
- 3010653892
- 3006437555
- 3019848304
- 3015391081
- 3008856821
- 3010374920
- 3043049733
- 9710020
- 3014437893
- 3014302716
- 3006798117
- 3017230140
- 3012268821
- 3019458442
- 3013006775
- 3008381089
- 3017467279
- 3011424870
- 3008339799
- 3017408377
- 3007479164
- 3014471045
- 3037040712
- 3010774780
- 3003965134
- 3042896810
- 3003890648
- 3012414867
- 3008298053
- 3012360512
- 3017461134
- 9616875
- 3012391162
- 3013496867
- 3044466317
- 3017103765
- 3005327291
- 9681151
- 3016622475
- 3005090771
- 3017884933
- 3011279497
- 3011529314
- 3030678923
- 3011676045
- 3013528379
- 3010141571
- 1932271
- 3010339057
- 3004158259
- 9680357
- 3014409525
- 9615551
- 3011545608
- 9616862
- 3013580507
- 9615909
- 3009489102
- 3014421917
- 3015167798
- 3017212217
- 3011310668
- 3004127972
- 3010155681
- 3013518061
- 3016450032
- 3014620201
- 3017846745
- 3009148458
- 3012207247
- 9616096
- 3016970619
- 3016968725
- 3004361903
- 3034629649
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FXO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914615 | BTP(TM) CENTRALINE(TM) SUIT | Btp Industries, Inc. | 1992-05-05 |
| K891212 | APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE | Pro-Safe Professional Linens, Inc. | 1989-04-14 |
| K882282 | SUIT, SURGICAL | A Plus International, Inc. | 1988-06-23 |
| K865022 | SURGICAL GARMENTS | Ulti-Med Intl., Inc. | 1987-01-12 |
| K822483 | MULTIPLE SCRUB SUIT | Surgilite Intl., Inc. | 1982-09-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases