DC Pack TM
FDA 510(k) K821134 · Seamless Hospital Products Co.
510(k) numberK821134
Submission
- Device name
- DC Pack TM
- Applicant
- Seamless Hospital Products Co.
Mchenry, IL, US - Received
- April 20, 1982
- Decision date
- June 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFC – Aspirator, Endocervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1050
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974032 | Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically AspiratorHFC · Traditional | A & A Medical, Inc. | 12/22/1997SE |
| K960263 | Cervical Mucous Aspiration CatheterHFC · Traditional | Cook Urological, Inc. | 08/29/1996SE |
| K954903 | Pedi Vaginal AspiratorHFC · Traditional | Cook Urological, Inc. | 04/29/1996SE |
| K954102 | SelectmucusHFC · Traditional | Select Medical Systems, Inc. | 11/21/1995SE |
| K902242 | Endocervical AspiratorHFC · Traditional | Innovative Medical Products, Inc. | 10/09/1990SE |
| K902032 | O. B. Pack IVHFC · Traditional | Customed, Inc. | 09/28/1990SE |
| K902954 | OBER2 Monitor, Eye Movement (Ophthalmic)HFC · Traditional | Permobil AB | 08/23/1990SE |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | Unimar, Inc. | 11/29/1989SE |
| K812175 | Endocervical AspiratorHFC · Traditional | Fertility Instrumentation, Inc. | 09/21/1981SE |
| K801238 | Accu-Pap T Zone SamplerHFC · Traditional | Robert Hasselbrack, M.D. | 08/12/1980SE |
More from Robert Hasselbrack, M.D.
Questions and answers
When was DC Pack TM cleared by the FDA?
DC Pack TM (K821134) received a 510(k) decision of Substantially Equivalent on June 22, 1982, 63 days after the submission was received.
What is the product code of K821134?
The FDA product code is HFC – Aspirator, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.