510(k) K923285
- Device
- Pro-tip Disposable 3/1 Syringe Nozzle
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K923285
- Product code
- ECB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-09-15
- Date received
- 1992-07-06
- Regulation
- 872.4565
- Classification name
- Unit, Syringe, Air And/Or Water
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN A NAYLOR
- Address
- 9400 King St. Franklin Park IL US 60131 60131
FDA Registration Numbers#
- 3038718579
- 3005688007
- 3004425647
- 3004605493
- 3032579800
- 3042228064
- 3006542438
- 2523320
- 2024980
- 1000179416
- 3011210208
- 3017910185
- 9611024
- 2433012
- 3008729549
- 3009219448
- 8010733
- 3019103
- 3035858919
- 3018047916
- 3025414363
- 3015461866
- 3004201548
- 3031582434
- 3038200645
- 3004187094
- 8010159
- 3009340886
- 3012925629
- 2437780
- 3002808270
- 3010598169
- 1032347
- 3043012074
- 3010583458
- 3043149902
- 3008346537
- 3008559238
- 3005728058
- 3026326493
- 3015168527
- 1219113
- 1836161
- 3000219976
- 3012477813
- 3003637274
- 3012421607
- 2424472
- 9680615
- 8044167
- 3022226
- 3024787345
- 3013496867
- 2086043
- 3003677417
- 3010896988
- 3003418325
- 3024088964
- 3011279497
- 3010147274
- 9611367
- 3015491448
- 3006210673
- 3015276580
- 3021386681
- 2435946
- 1051614
- 8043554
- 3027234828
- 3009420946
- 3043011436
- 2133714
- 3017498782
- 1941138
- 3005938413
- 3005791927
- 3011707926
- 3014683120
- 3012336822
Source Documents#
Other 510(k) Records For Product Code ECB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942519 | UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS | Bull Frog Mfg. Co. | 1994-08-23 |
| K931772 | SURETIP SYRINGE TIP COVER | Western M/D, Inc. | 1994-03-07 |
| K931137 | DENTAL SYRINGE TIP | A-Dec, Inc. | 1993-11-29 |
| K923876 | RISKONTROL SINGLE USE | Riskontrol | 1993-04-05 |
| K920499 | SANI-TIP | Dw Industries, Inc. | 1992-05-03 |
| K911756 | POSTERIOR NASAL EPISTAXIS INSTRUMENTS | Richard Wolf Medical Instruments Corp. | 1991-10-24 |
| K890290 | BRACE (ORAFIX SPECIAL) | Norcliff Thayer, Inc. | 1989-03-29 |
| K863024 | SERINGA TRIPLICE S.L. | Sds Dental, Inc. | 1986-09-25 |
| K854699 | TUBING SYRING | Almore Intl., Inc. | 1986-01-06 |
| K801686 | SPACELINE THREE WAY SYRINGE | Pacific Dental Corp. | 1980-08-04 |
| K781594 | DENTAL WARM WATER IRRIGATING SYSTEM | Rama Corp. | 1978-12-04 |