The following data is part of a premarket notification filed by Seamless Hospital Products Co. with the FDA for Dc Pack Tm.
| Device ID | K821134 |
| 510k Number | K821134 |
| Device Name: | DC PACK TM |
| Classification | Aspirator, Endocervical |
| Applicant | SEAMLESS HOSPITAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HFC |
| CFR Regulation Number | 884.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-20 |
| Decision Date | 1982-06-22 |