510(k) K883766
- Device
- Mouth-to-mask Ventilatory Adjunct
- Applicant
- MEDIC ONE
- 510(k) number
- K883766
- Product code
- KGB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-21
- Date received
- 1988-09-06
- Regulation
- 868.5570
- Classification name
- Mask, Oxygen, Non-Rebreathing
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAN WHITE
- Address
- 9400 E. 17th Independence MO US 64052 64052
FDA Registration Numbers#
- 3008264111
- 3010272829
- 3011987967
- 2020813
- 3003674698
- 3004134948
- 3016450032
- 3034669683
- 3010957755
- 3005621808
- 3017609572
- 3010400865
- 3006897996
- 3010380285
- 3006547005
- 3005587132
- 3003887292
- 3017417635
- 3010834934
- 3015997711
- 3020777588
- 3017202422
- 9681848
- 3013510193
- 8030673
- 3011529314
- 3016758972
- 3038274448
- 3012607778
- 8021995
- 3003528228
- 3010452651
- 3008818980
- 3016452400
- 3029917416
- 3005460813
- 3009540516
- 3004361444
- 3032579548
- 9611500
- 3029706818
- 3015191173
- 9610861
- 3009171220
- 3010594263
- 1024404
- 3000153466
- 3021244152
- 3011716786
- 3010402691
- 3020751316
- 3007963782
- 3006446479
- 3012250536
- 3022568093
- 3003862188
- 3006210673
- 3008806809
- 8030607
- 9680222
- 3009771213
- 1922553
- 3027645738
- 3008567544
- 3005273623
- 9710391
- 3011280379
- 3026263452
- 3003902312
- 3017937889
- 3010656982
- 3034605486
- 1836161
- 3007127332
- 3013513837
- 3004748541
- 3012711490
- 3004993040
- 3013034812
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KGB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970688 | POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 |
| K960401 | ULTIMATE SEAL | Hans Rudolph, Inc. | 1996-06-20 |
| K941336 | COMBO MASK | Gam Industries, Inc. | 1994-09-09 |
| K935917 | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-02-04 |
| K932347 | COMPACT MASK | Vital Signs, Inc. | 1994-01-10 |
| K933583 | NONREBREATHING VALVE | Hans Rudolph, Inc. | 1994-01-03 |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | Laerdal Medical Corp. | 1993-12-02 |
| K930336 | PROFAST(R)-DENTURE ADHESIVE CREAM | Fittydent-Altwirth & Schmitt GmbH | 1993-08-24 |
| K913164 | NON REBREATHING MASK | Specialty Packaging Producs, Inc. | 1992-01-15 |
| K790161 | OXYGEN MASK W/RESERVOIR BAG | Airlife, Inc. | 1979-04-20 |
| K790162 | OXYGEN MASK, CONCENTRATION AEROSOL MASK | Airlife, Inc. | 1979-04-20 |
| K781414 | MASK, OXYGEN, NONBREATHING | Vitalab Products Corp. | 1978-09-07 |