510(k) K912179
- Device
- The Spritz Bath
- Applicant
- THE SPRITZ CO.
- 510(k) number
- K912179
- Product code
- KTC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-28
- Date received
- 1991-05-16
- Regulation
- 890.5125
- Classification name
- Bath, Sitz, Nonpowered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONNA L VALVERDE
- Address
- 9618 Fairdale Ln. Houston TX US 77463 77463
FDA Registration Numbers#
- 3015173212
- 8030903
- 3009674182
- 3018503755
- 3005669815
- 3018074706
- 3013429260
- 3043648106
- 3015009174
- 3012316249
- 2648727
- 3038613790
- 3013057712
- 2183887
- 1043646
- 3007607706
- 3016068274
- 3006636962
- 3014383382
- 8040884
- 3016171914
- 3030539818
- 3000153466
- 3010409218
- 1523547
- 3007681502
- 3012568936
- 3004111573
- 3014982318
- 3011919098
- 1641302
- 1420054
- 3038279528
- 1422399
- 3008656885
- 3033884638
- 3006673317
- 3013627744
- 3010339057
- 9615019
- 3035374295
- 8022890
- 3008467060
- 3007082185
- 3010964789
- 1928237
- 3006537699
- 3004122598
- 3013263114
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890085 | SIT-N-BATHE SITZ BATH | Drummond Industries, Inc. | 1989-02-13 |
| K862600 | SITZ BATH | W. C. Green, D.D.S. | 1986-07-18 |
| K851309 | ABCO PLASTIC UTENSILS | Abco Dealers, Inc. | 1985-07-01 |
| K841711 | MAC LEE SITZ BATH | Mac Lee Medical Products | 1984-05-07 |
| K831762 | SITZ BATH, SINGLE PATIENT USE #8100 | Lsl Industries, Inc. | 1983-06-24 |
| K800958 | PERSONAL SITZ BATH KIT | The Healthcare Group Laboratories, Inc. | 1980-05-02 |