510(k) K760307
- Device
- BEDPAN, SINGLE PATIENT USE, TECNOL
- Applicant
- TECNOL NEW JERSEY WOUND CARE, INC.
- 510(k) number
- K760307
- Product code
- FOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-08-11
- Date received
- 1976-07-26
- Regulation
- 880.6730
- Classification name
- Bedpan
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 368 Fairview Ave. Hammonton NJ US 08037 08037
FDA Registration Numbers#
- 3008467060
- 3045058049
- 3031184338
- 3017309443
- 3002974712
- 3013358456
- 1526611
- 3004496839
- 1930034
- 3010595915
- 1480288
- 3017231740
- 3011137372
- 3014264913
- 3016734231
- 3009703496
- 3010987649
- 3013495708
- 3015997711
- 9680909
- 1218386
- 3004168759
- 3005187671
- 3017674087
- 3015058854
- 2648727
- 3003431869
- 3007048220
- 3008338766
- 3015337373
- 3012316249
- 3008902714
- 3014615175
- 3027847726
- 3034669683
- 3038613790
- 3013298431
- 3001644167
- 3013429260
- 3016758972
- 3012034017
- 1417592
- 3038472985
- 3008572946
- 3004122598
- 3008386649
- 3042262500
- 1523547
- 2435946
- 8022077
- 3004014152
- 3010700223
- 3021167963
- 3014683120
- 9613910
- 3010041511
- 1928237
- 8040278
- 3006210673
- 2518897
- 3024088964
- 1034116
- 1836161
- 8043410
- 3007218972
- 3006636962
- 3005327291
- 3007420694
- 1422443
- 3012104670
- 3008496560
- 1641302
- 3010339057
- 3015332629
- 3013875443
- 3009408502
- 3010964789
- 3017638267
- 3013263114
- 8022890
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FOB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K791346 | DISPOSABLE BEDPAN | General Clinical Plastics Corp. | 1979-08-03 |
| K780370 | STAND UP TOILET | Medical Specialty Products, Inc. | 1978-04-10 |
| K760490 | BEDPAN, GENERAL MEDICAL MEDI-PAK | Landmark Plastics | 1976-11-12 |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | Bemis Health Care | 1976-08-23 |
Legacy Summary#
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FDA Review#
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