510(k) K792391
- Device
- COTTON ROLL COMPRESSION CAPS
- Applicant
- PARKER LABORATORIES, INC.
- 510(k) number
- K792391
- Product code
- EFN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-06
- Date received
- 1979-11-26
- Regulation
- 872.6050
- Classification name
- Cotton, Roll
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014314985
- 1250045
- 3009307523
- 3017041963
- 3012922212
- 3043648115
- 3021282544
- 3014883395
- 1422598
- 3011526299
- 3015745029
- 3005460813
- 3003418325
- 3008352964
- 3012309743
- 8010414
- 3007187674
- 3007865243
- 3026603463
- 3015173437
- 3014368824
- 1417592
- 3016758972
- 1055236
- 9680934
- 3015043014
- 1423537
- 3030017177
- 3011434305
- 2028046
- 3045030541
- 3004753358
- 3007165189
- 3010155661
- 3013530901
- 2027062
- 9611959
- 3004938767
- 2183301
- 3015214015
- 2511556
- 3004605321
- 9680222
- 3012137459
- 3010621964
- 3026263452
- 1060680
- 3005688007
- 3013632692
- 3015045320
- 2437780
- 3044819802
- 3014683120
- 3029507159
- 3044466317
- 3010864832
- 3010957766
- 3009542933
- 3009219448
- 2014676
- 3011707926
- 3016170492
- 3017475063
- 3003487388
- 2182318
- 3016763307
- 2521453
- 3026630
- 3008559238
- 3008485841
- 3038718579
- 3030528528
- 3005273623
- 3010383831
- 2523320
- 1061124
- 3004111573
- 3009420946
- 3010656982
- 1836161
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EFN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872810 | STRUNG DENTAL ROLLS | American Silk Sutures, Inc. | 1987-12-04 |
| K871464 | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER | Medgroup Enterprises, Inc. | 1987-04-30 |
| K863764 | COTTON ROLLS, NON-STERILE | The Medical Group, Inc. | 1986-10-27 |
| K861338 | DENTAL COTTON ROLLS, STERILE AND NON-STERILE | Intl. Verbandstoff-Fabrik Schaffhau | 1986-08-06 |
| K861727 | COTTON FILLED GAUZE SPONGES 2 X 2 | Cross Country Paper Products Corp. | 1986-07-10 |
| K843539 | TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- | Molnlycke A/S Hospital Products | 1985-05-23 |
| K841327 | DENTAL COTTON ROLLS | Intl. Verbandstoff-Fabrik Schaffhau | 1984-07-03 |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Henry Schein, Inc. | 1984-02-03 |
| K830175 | STERILE COTTON ROLLS #3, 1 1/2 | Veratex Corp. | 1983-02-18 |
| K812709 | STERILE DENTAL ROLL | Medspec Corp. | 1981-10-23 |
| K810830 | HOYT COTTON ROLLS | Hoyt Laboratories | 1981-04-14 |
| K802429 | COTTON ROLLS | Worldwide Surgical Gauze | 1980-10-23 |
| K770063 | DISP. ABSORBENT COMPRESSED FIBRE WAFER | Lorvic Corp. | 1977-01-14 |
Legacy Summary#
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FDA Review#
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