510(k) K961502
- Device
- LUBRICATING JELLY, LOW VISCOSITY
- Applicant
- SPAN-AMERICA MEDICAL SYSTEMS, INC.
- 510(k) number
- K961502
- Product code
- KMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-18
- Date received
- 1996-04-19
- Regulation
- 880.6375
- Classification name
- Lubricant, Patient
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- POLLY THOMPSON
- Address
- 70 Commerce Dr. P.O. Box 5231 Greenville SC US 29615 29615
FDA Registration Numbers#
- 3042200051
- 3004472810
- 2531449
- 1423537
- 2094377
- 3006425876
- 2110701
- 3017635043
- 2029275
- 3012777736
- 3011193403
- 3014656749
- 1423662
- 3007289408
- 3031190571
- 3003071219
- 3016171962
- 3011529681
- 3012110942
- 3010165308
- 3012568936
- 3042283853
- 3015997711
- 3009086335
- 3015538858
- 3017889736
- 3013162291
- 8030128
- 3003610251
- 9616088
- 3006455037
- 1054241
- 1928237
- 3009482034
- 3001313714
- 3014848316
- 3003963141
- 3005580113
- 3017911818
- 3038624837
- 3032109
- 1921846
- 3014326210
- 1055236
- 3010223399
- 3010419931
- 3004111573
- 3027341451
- 2212018
- 3012309743
- 9612030
- 1061124
- 3005012805
- 3009134882
- 3014686987
- 2027062
- 2022435
- 3004748528
- 1060680
- 3017376191
- 2320762
- 1043214
- 3033840300
- 3014637079
- 3013865802
- 3004513970
- 3003059934
- 3010623099
- 3012104670
- 3013298431
- 3025440611
- 1424263
- 3010164364
- 3011318803
- 1417592
- 2025771
- 2938651
- 3015058854
- 3003207991
- 3016005033
Source Documents#
Other 510(k) Records For Product Code KMJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142473 | Lubricating Jelly | Sion Biotext Medical , Ltd. | 2015-04-13 |
| K141028 | COLONGLIDE LUBRICANT | Pediatric Pharmaceuticals, Inc. | 2014-07-24 |
| K131617 | COLONGLIDE(R) LUBRICANT | Pediatric Pharmaceuticals, Inc. | 2013-10-03 |
| K121390 | LUBE JELLY SURINGE | Nurse Assist, Inc. | 2012-08-10 |
| K113689 | DUKAL LUBRICATING JELLY | Dukal Corporation | 2012-05-04 |
| K112110 | STERILE LUBRICATING JELLY | Jianerkang Medical Dressing Company | 2012-04-10 |
| K103718 | DYNACOR LUBRICATION GEL | Medline Industries, Inc. | 2011-05-10 |
| K101522 | ULTRA SEAL STERILE LUBRICATING JELLY | Ultra Seal Corporation | 2010-12-23 |
| K092488 | DYNAREX STERILE LUBRICATING JELLY | Dynarex Corporation | 2009-12-18 |
| K083189 | STERI-LUB LUBRICATION GEL | Avail Medical Products, Inc. | 2008-11-21 |
| K073684 | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 |
| K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | Spirus Medical, Inc. | 2008-04-03 |
| K042563 | DUREX PLAY WARMER LUBRICANT | Ssl Americas, Inc. | 2005-02-23 |
| K041060 | E-Z LUBRICATING JELLY | Chester Labs, Inc. | 2004-05-07 |
| K020586 | GOOD LUBRICATIONS | Biofilm, Inc. | 2003-01-24 |
Legacy Summary#
summary
FDA Review#
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