510(k) K083457
- Device
- TACTIPEN
- Applicant
- HASELMEIER GMBH
- 510(k) number
- K083457
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-13
- Date received
- 2008-11-21
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN J GOLDNER, JD, RAC
- Address
- 30833 Northwestern Hwy. Suite 121 Farmington Hills MI US 48334 48334
FDA Registration Numbers#
- 9616157
- 3008717264
- 9610825
- 1219205
- 3004499989
- 3003681915
- 3015806723
- 3010197239
- 1526534
- 3011088743
- 3013496867
- 3009551627
- 2320767
- 3030626857
- 1423929
- 1915484
- 1313700
- 2183449
- 2950467
- 9611390
- 8021538
- 3010419931
- 3015997711
- 1211998
- 3009746425
- 1217831
- 3010621964
- 3010321647
- 3017494520
- 3009761558
- 3014456066
- 3012410077
- 3005862821
- 3014579161
- 3008114965
- 9610726
- 3009337401
- 3005405146
- 3035455509
- 2025816
- 3014262693
- 3016851379
- 9680425
- 3006380458
- 2032227
- 1054811
- 1018120
- 3018681450
- 1518293
- 3015724777
- 3009328501
- 3029755538
- 3010175289
- 3010377171
- 3044994889
- 3013221738
- 2521402
- 1226146
- 3017509841
- 3035111606
- 1060680
- 1721504
- 3043226252
- 3009742443
- 3005798905
- 3010384323
- 3043709866
- 3010432890
- 3005581234
- 3013421458
- 8031563
- 3003310007
- 3011689956
- 3038294399
- 3002907620
- 3012302888
- 3004142400
- 3009302820
- 1055236
Source Documents#
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | 2025-08-22 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025-06-24 |
| K250262 | GO-PEN® | Go-Pen Aps | 2025-04-24 |
Legacy Summary#
summary
FDA Review#
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