510(k) K931772
- Device
- SURETIP SYRINGE TIP COVER
- Applicant
- Western M/D, Inc.
- 510(k) number
- K931772
- Product code
- ECB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-07
- Date received
- 1993-04-09
- 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
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBERT NERLI
- Address
- 1320 Marsten Rd. #A-B Burlingame CA US 94010 94010
FDA Registration Numbers#
- 3008559238
- 3009219448
- 3005728058
- 3012925629
- 3010598169
- 3011713204
- 2182318
- 1032347
- 3014345250
- 3026326493
- 2029234
- 3015276580
- 3012922212
- 3018047916
- 3004187094
- 3004605493
- 3044819802
- 3002105090
- 9611367
- 3044150131
- 3008346537
- 3011434305
- 1000179416
- 3010741366
- 3010198795
- 3021386681
- 3015168527
- 3043011436
- 3003418325
- 3008729549
- 8043554
- 3010057414
- 3024787345
- 3010147274
- 3040278125
- 1036212
- 3017498782
- 3015461866
- 3006608997
- 3007622273
- 3017609565
- 3017759006
- 3008370577
- 3015045320
- 3000286616
- 3016170492
- 3042367543
- 3006210673
- 8044167
- 3032579800
- 3013506123
- 3012421607
- 3011210208
- 3006542438
- 2523320
- 1319447
- 3021666757
- 3002808270
- 2437780
- 8010159
- 3005938413
- 9611024
- 3045855232
- 3014683120
- 3019103
- 3014334038
- 3038200645
- 3000219976
- 3009340886
- 3029780
- 3045058049
- 3043012240
- 3027320022
- 3021023132
- 9616872
- 3012336822
- 1319130
- 1051614
- 3031582434
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K931137 | DENTAL SYRINGE TIP | A-Dec, Inc. | 1993-11-29 |
| K923876 | RISKONTROL SINGLE USE | Riskontrol | 1993-04-05 |
| K923285 | PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE | Smith & Nephew, Inc. | 1992-09-15 |
| 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 |