510(k) K890734
- Device
- DRY TIPS
- Applicant
- MICROCOPY, DIV. NEO-FLO, INC.
- 510(k) number
- K890734
- Product code
- KHR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-10
- Date received
- 1989-02-13
- Regulation
- 872.6050
- Classification name
- Absorber, Saliva, Paper
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAASS, JR.
- Address
- 3120 Moon Station Rd. Kennesaw GA US 30144 30144
FDA Registration Numbers#
- 3022516928
- 3008392711
- 3003423103
- 3003675658
- 3005728058
- 3023339277
- 3017417635
- 1319639
- 3008352964
- 2182318
- 3014345250
- 2029234
- 3005176727
- 3014314985
- 3016195240
- 3001650535
- 3015276580
- 3017103765
- 3044819802
- 3044150131
- 3017949824
- 3008346537
- 3011434305
- 1000179416
- 3010198795
- 3015168527
- 3010287652
- 3015745029
- 3011091529
- 3016649599
- 8030607
- 3005078659
- 3024787345
- 3008496560
- 3026844237
- 3010147274
- 3013575574
- 3026630
- 3017498782
- 3017609565
- 3010383831
- 3017113900
- 3008370577
- 3014626425
- 3015045320
- 2023633
- 3016170492
- 3042367543
- 1043214
- 3031184338
- 3006210673
- 3013506123
- 3017231740
- 3012421607
- 3016758972
- 3011210208
- 3026858378
- 3029802606
- 3010595915
- 3006123105
- 3003230618
- 2437780
- 3010374972
- 2031532
- 3009308092
- 3029507159
- 3045855232
- 3002651668
- 3015287618
- 3014683120
- 3011556876
- 8030052
- 3016450032
- 3045058049
- 3017461111
- 3027320022
- 3026222938
- 3021023132
- 3003794907
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KHR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980783 | SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 | Irt Management Corp. | 1998-04-21 |
| K954068 | GENERAL HYGIENE KIT | Physician Industries, Inc. | 1995-11-08 |
| K953812 | GAUZE SPONGE | Remington Medical, Inc. | 1995-10-02 |
| K891054 | NON-STERILE GAUZE SPONGE | Dispomed, Inc. | 1989-05-01 |
| K891354 | ORTHODONTIC COTTON ROLL HOLDERS | American Orthodontics | 1989-04-17 |
| K870383 | ALGINATE WOOL FIBER | Adri | 1987-04-30 |
| K850988 | BOVO MOISTURE GUARD | E.H. Medical Co. | 1985-04-16 |
| K780400 | DEN-Z-ORB | Nice-Pak Products, Inc. | 1978-03-27 |
| K771908 | ISO-SHIELD SALIVA ABSORBERS | 3M Company | 1977-11-07 |
Legacy Summary#
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FDA Review#
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